How do umbilical cord, bone marrow and adipose stem cells compare in the laboratory?

The laboratory comparisons report trade-offs between the sources. Kern and colleagues found isolation in 100 percent of marrow and adipose samples and 63 percent of cord blood samples, with cord blood cells proliferating most [4], and Jin and colleagues found similar markers and immunosuppressive activity across the three with lower senescence markers in cord blood cells [5]. No head-to-head clinical trial has compared sources [3].

What is Wharton’s jelly?

The gelatinous connective tissue of the umbilical cord that surrounds the cord vessels. Secunda and colleagues isolated MSCs from it by enzymatic and explant methods and reported faster isolation and higher yield than cord blood [6]. On this site Wharton’s jelly cells appear in the IND context, such as the 10-patient phase I trial reported by Soder and colleagues [11].

How are donor stem cells screened and tested?

From the standpoint of communicable disease, 21 CFR 1271 requires screening of every donor’s records and testing of a donor specimen for HIV-1 and HIV-2, hepatitis B and C and Treponema pallidum, with HTLV and cytomegalovirus added for leukocyte-rich cells [24, 26]. The FDA consumer alert states that many promoted products are illegally marketed, have not been shown to be safe or effective, and in some cases may have significant safety issues [20].

Embryonic vs adult stem cells, what is the difference?

Embryonic lines, first derived by Thomson and colleagues in 1998, are pluripotent and remain research tools [16], as do the induced pluripotent lines Takahashi and colleagues made from adult fibroblasts in 2007 [17]. Adult and perinatal stem cells are multipotent, forming a limited set of lineages, and are the only group that tissue banks supply [15].

Which stem cell source is FDA approved?

The FDA states that the only approved stem cell products are blood-forming cells from umbilical cord blood, licensed for hematopoietic reconstitution [20, 22], and in December 2024 it licensed one culture-expanded bone marrow MSC product for a single pediatric indication [21]. The current FDA list also includes gene-modified hematopoietic stem cell products made from a patient’s own cells, such as CASGEVY and ZYNTEGLO, and OMISIRGE, made from cord blood [27]. Products from adipose tissue, Wharton’s jelly and amniotic fluid are named by the agency as unapproved [20].

Does donor age affect stem cell quality?

For bone marrow it does. Siegel and colleagues studied 53 donors aged 13 to 80 and reported higher expression of several adhesion markers, less IL-6 production and more high-clonogenic cells in younger donors, with differentiation unaffected by age or sex [9]. Perinatal sources are collected at birth, which removes donor age as a variable [4].

How do I know where a tissue bank’s cells came from?

The certificate of analysis names the tissue of origin and carries the donor screening and serology record under 21 CFR 1271.75 and 1271.85, the ISCT identity panel by flow cytometry, the passage at harvest, and the post-thaw viability figure [2, 24, 26]. ExaVeyra makes the certificate, characterization panel and cold-chain records available on request for every lot.

Are umbilical cord stem cells the same as cord blood stem cells?

No. Cord blood yields hematopoietic progenitor cells, the licensed products for transplantation [22], and a minority of mesenchymal cells, with isolation succeeding in 63 percent of samples [4]. Cord tissue, including Wharton’s jelly, yields mesenchymal cells more readily [6], and the two sources are named separately on a certificate.

5 November 2026 · Updated November 2026 · 15 min read

Where Do Stem Cells Come From? Seven Sources and What Each One Yields

Where do stem cells come from? Seven sources, from bone marrow and fat to umbilical cord tissue and placenta, what each one yields and how it is tested.

Stem CellsMesenchymal Stem CellsUmbilical CordBone MarrowDonor ScreeningISCT CriteriaTissue BanksPractitioner Guides

Benn Bluestein-Veyra, M.Sc. Organic Chemistry | ExaVeyra Sciences

Cited sources

Stem cells used in medicine come from a short list of tissues: adult bone marrow and adipose tissue, perinatal tissues collected at birth (umbilical cord blood, umbilical cord tissue, placenta and amniotic fluid), dental pulp, and, in research only, embryonic and induced pluripotent cell lines. Kern and colleagues compared three of those sources in 2006 and reported that mesenchymal stem cell isolation succeeded in 100 percent of bone marrow and adipose samples and 63 percent of cord blood samples, while the cord blood cells expanded to the highest numbers [4].

Each source below is read against the same frame: the criteria that define a mesenchymal stem cell, the donor screening and testing that every allogeneic cell product passes under 21 CFR 1271, how the source changes yield and doubling, and what a tissue bank’s documentation shows about all of that. ExaVeyra Sciences supplies mesenchymal stem cells from an FDA-registered tissue bank to practices in states whose laws permit it, and every clinical decision described here belongs to the practitioner.

tissue sources compared in the source table, from bone marrow to the pluripotent research lines

53 donors

aged 13 to 80 in the bone marrow MSC study that linked donor age to marker expression and clonogenicity (Siegel 2013)

10 patients

in the phase I trial of Wharton’s jelly cells conducted under an IND, read in the trials section (Soder 2020)

Regulatory status

The FDA states that the only approved stem cell products consist of blood-forming stem cells derived from umbilical cord blood, and names products derived from adipose tissue, cord blood, Wharton’s jelly and amniotic fluid as widely promoted and unapproved [20]. The agency’s current approved-products list also includes gene-modified hematopoietic stem cell products made from a patient’s own cells, and OMISIRGE, made from cord blood [27]. One culture-expanded bone marrow MSC product received a US license on 18 December 2024 for a single pediatric indication [21]. Most mesenchymal stem cell products are section 351 biologics that require an IND or a biologics license, and that status applies in every state. ExaVeyra supplies mesenchymal stem cells from an FDA-registered tissue bank to practices in states whose laws permit it, and the practitioner and their counsel decide use.

Embryonic, induced pluripotent and adult stem cells differ in what they can form

Thomson and colleagues derived the first human embryonic stem cell lines from blastocysts produced by in vitro fertilization in 1998 [16], and Takahashi and colleagues produced induced pluripotent stem cells from adult human fibroblasts with four defined factors in 2007 [17]. Both are pluripotent, which means they can form cells of every lineage, and both remain research tools: neither appears in any tissue bank catalog and neither is sold to a practice.

Adult and perinatal stem cells are multipotent, which means they form a limited set of lineages. Pittenger and colleagues showed in 1999 that cells expanded from adult human bone marrow differentiate to bone, cartilage and fat [15], and that three-lineage result became part of the definition of a mesenchymal stem cell [2]. Every product a tissue bank supplies to a practice comes from this multipotent group.

The ISCT minimal criteria define what counts as a mesenchymal stem cell

Dominici and colleagues published the International Society for Cellular Therapy minimal criteria in 2006: the cells must adhere to plastic in standard culture, must express CD105, CD73 and CD90 while lacking CD45, CD34, CD14 or CD11b, CD79alpha or CD19 and HLA-DR, and must differentiate to osteoblasts, adipocytes and chondroblasts in vitro [2]. A flow cytometry panel against those markers is the identity test on a certificate of analysis.

Viswanathan and colleagues updated the nomenclature for the ISCT committee in 2019, recommending that the acronym MSC be qualified by the tissue of origin and that the term mesenchymal stromal cell be used unless stemness has been shown by rigorous in vivo evidence [1]. Galipeau and Sensébé reported in 2018 that advanced MSC trials have fallen short of the expectations raised by animal data, and traced part of the gap to tissue source, culture and cryopreservation [3].

The practical reading is that a source label such as bone marrow or umbilical cord tissue is part of the product’s name, and that the markers on the certificate are the evidence the label rests on. Hass and colleagues reviewed the sources in 2011 and reported that MSCs sit in perivascular niches in nearly all tissues, with the local milieu shaping proliferation, markers and immune function [7].

Published comparisons show how source changes yield and doubling

Kern and colleagues reported in 2006 that colony frequency was highest in adipose tissue and lowest in cord blood, that cord blood cells could be cultured longest with the highest proliferation, and that cord blood MSCs showed no adipogenic differentiation [4]. Jin and colleagues compared the same three sources in 2013 and reported similar surface antigens, immunosuppressive activity and differentiation, with cord blood MSCs showing the highest proliferation and clonality and lower expression of the senescence markers p53, p21 and p16 [5].

Secunda and colleagues added Wharton’s jelly to the comparison in 2015, isolating it by enzymatic and explant methods, and reported that it outperformed cord blood in rapidity, yield and ease of procedure, while marrow and adipose collection required an invasive procedure [6]. Strioga and colleagues reviewed adipose against marrow cells in 2012 and reported easier isolation and larger amounts from adipose tissue, with differences in immunophenotype and immunomodulatory activity that may partly reflect isolation and culture protocols [8].

Source	How it is collected	What the comparisons report	Where it appears
Bone marrow	Aspiration from the iliac crest, an invasive procedure [4, 6]	Isolation in 100 percent of samples; shortest culture period and lowest proliferation of the three sources compared [4]	The licensed culture-expanded MSC product [21]; autologous orthopedic procedures
Adipose tissue	Liposuction or excision	Isolation in 100 percent of samples; highest colony frequency; larger yields than marrow [4, 8]	Autologous procedures; the FDA names adipose-derived products as unapproved [20]
Umbilical cord blood	Collected from the cord and placenta after delivery	Isolation in 63 percent of samples; longest culture and highest proliferation; no adipogenic differentiation [4, 5]	Licensed hematopoietic products for transplantation [22]; MSC research
Umbilical cord tissue (Wharton’s jelly)	The cord matrix, processed by enzyme or explant after delivery [6]	Faster isolation and higher yield than cord blood [6]	IND trials such as the 10-patient phase I study [11]
Placenta and amniotic fluid	Afterbirth tissue and amniocentesis fluid	Multipotent lines isolated from amniotic fluid [19]; neonatal milieu shapes function [7]	Research and IND trials; the FDA names amniotic fluid products as unapproved [20]
Dental pulp	Extracted teeth	Clonogenic, highly proliferative cells that formed dentin-like tissue in vivo [18]	Research
Embryonic and induced pluripotent lines	Blastocysts from IVF [16]; reprogrammed adult fibroblasts [17]	Pluripotent	Research only

Donor age and sex shape the cells a bank receives

Siegel and colleagues isolated bone marrow MSCs from 53 donors aged 13 to 80 and reported in 2013 that cells from younger donors expressed more MCAM, VCAM-1, ALCAM and PDGFRβ and produced less IL-6 with activated T cells, that high-clonogenic cells were more frequent in younger female donors, and that mesodermal differentiation was unaffected by donor age or sex [9]. Kern and colleagues had already noted the decline in marrow MSC number and differentiation potential with donor age as a reason perinatal sources were introduced [4].

This is why a tissue bank records donor characteristics with each lot, and why a perinatal source, collected at birth, removes donor age as a variable. The remaining variables are the processing, the culture passage and the cold chain, each of which appears in the documentation discussed below.

Donor eligibility under 21 CFR 1271 applies to every allogeneic source

An allogeneic product comes from another person, and 21 CFR 1271 subpart C sets what the establishment must do before that person’s cells are released. Under 1271.75 the establishment reviews the donor’s medical records for risk factors for and clinical evidence of HIV, hepatitis B, hepatitis C, human transmissible spongiform encephalopathy and Treponema pallidum, and for viable leukocyte-rich cells, human T-lymphotropic virus [24].

Under 1271.85 a specimen from every donor is tested for HIV-1, HIV-2, hepatitis B virus, hepatitis C virus and Treponema pallidum, with HTLV-I, HTLV-II and cytomegalovirus added for viable leukocyte-rich cells [26]. For a donor one month of age or younger, which covers every cord and placental donation, 1271.80 directs that the specimen come from the birth mother, collected at recovery or within seven days of it [25].

Those records document the communicable disease screening and testing that 21 CFR 1271 requires of every donor, and they form the serology section of a certificate of analysis. The regulation defines an HCT/P as an article containing or consisting of human cells or tissues intended for implantation, transplantation, infusion or transfer, and defines minimal manipulation for cells as processing that does not alter their relevant biological characteristics [23].

Several questions about source remain open in the published evidence

The comparisons above are laboratory studies, and a reader should know what they do not settle. The points below set out what the published evidence does not yet show.

Clinical superiority of one source is unproven: Galipeau and Sensébé reported that advanced MSC trials have fallen short of preclinical expectations, and no head-to-head trial has compared sources in the same indication [3].
Laboratory comparisons use different protocols: Strioga attributed some reported differences between adipose and marrow cells to isolation and culture methods rather than biology [8].
Donor effects are documented for marrow and less so for perinatal tissue: the 53-donor study concerned bone marrow only [9].
Freeze-thaw effects differ from fresh cells in the laboratory, and the clinical size of that difference remains under study [10].
The Wharton’s jelly evidence is early: the 10-patient phase I trial reported safety and a response signal under an IND, with no control arm [11].
Nomenclature is unsettled: the 2019 ISCT statement asks for the source to qualify the acronym and reserves the word stem for cells with in vivo evidence of stemness [1].

Wharton’s jelly cells appear in registered investigational trials

Soder and colleagues ran a phase I two-cohort trial under an IND in 10 patients after allogeneic transplantation, using Wharton’s jelly cells isolated, expanded and cryostored under GMP, and reported no infusion-related toxicity, no related adverse events to day 42, no ectopic tissue at day 90, and an overall response of 70 percent at day 28 [11]. That registered setting is the context in which Wharton’s jelly cells appear on this site.

The licensed culture-expanded MSC product comes from adult bone marrow: Kurtzberg and colleagues reported a day 28 overall response of 70.4 percent against a prespecified control of 45 percent in 54 children [12], and the ISCT committee read the December 2024 approval as the first US license for such a product [13, 21]. Turner and colleagues analyzed 300 US businesses selling allogeneic perinatal cell products in 2024 and cataloged the brand names and suppliers, which shows how far the marketplace has moved toward perinatal sources outside those registered routes [14].

A source label is part of a cell product’s name. The flow cytometry panel, the donor serology record and the post-thaw viability figure are the evidence the label rests on, and a tissue bank files them with every lot.

A tissue bank’s documentation shows the source, the donor record and the release tests

A practice reading a certificate of analysis for the first time can check the source claim against four sections. The identity panel reports the ISCT markers by flow cytometry [2]; the donor section carries the screening and serology record under 1271.75 and 1271.85 [24, 26]; the release section reports viability, sterility, endotoxin and mycoplasma; and the handling section states the storage temperature and the thaw window.

The thaw window matters because Moll and colleagues reported in 2014 that freeze-thawed MSCs showed impaired immunomodulatory and blood regulatory properties and stronger complement activation than freshly harvested cells [10]. ExaVeyra ships cell products frozen with the lot number on every vial, and the certificate of analysis with serology, the characterization panel and the cold-chain records for a lot are available on request.

Source and donor: tissue of origin named on the certificate, with the donor screening and testing record under 21 CFR 1271 subpart C [24, 25, 26]
Identity: percentage of cells positive for CD105, CD73 and CD90 and negative for the hematopoietic markers and HLA-DR [2]
Passage and doubling: the culture passage at harvest and, where reported, the population doubling time, which the comparative studies link to source [4, 5]
Viability: a post-thaw count by dye exclusion or flow cytometry, with the thaw instructions the figure assumes [10]
Safety: sterility, endotoxin and mycoplasma results for the lot
Storage: the temperature, the shipper and the logger record from release to receipt

A verified account puts the source documentation in the practice file

A practice that understands where its cells come from can read a certificate against the source claim, the donor record and the release panel, and file all three with the lot. ExaVeyra supplies mesenchymal stem cells from an FDA-registered tissue bank that ships to all 50 states and Puerto Rico, to practices in states whose laws permit it, with the 351 biologic status applying everywhere.

Anyone may ask the scientific team a question or apply for an account without an NPI, and NPI review takes 1 to 3 business days. Verification gives access to the practitioner portal, product documentation and pricing for each available format, and the practices that start from the documentation are well placed to follow the source literature as it matures.

Educational Disclaimer: This article is for educational purposes only and does not constitute medical or legal advice. It does not identify any material, compound, device setting or protocol as safe, effective or appropriate for any patient, and it is not intended to diagnose, treat, cure, or prevent any disease. Questions about a treatment belong with the reader’s own licensed provider. Exosome material is supplied for topical aesthetic use by licensed practitioners. No exosome product is FDA-approved for any use, and ExaVeyra Sciences makes no statement about administration, route, or outcome. Compounded medications are not FDA-approved. They are prepared by a 503A compounding pharmacy licensed by the Texas State Board of Pharmacy for an individual patient against that patient’s prescription, and are available to NPI-verified licensed practitioners only, in the states where the pharmacy is licensed. Product, device and brand names mentioned are trademarks of their respective owners and are used only to identify the products discussed. Their mention is not an endorsement, and those owners have not reviewed or endorsed this article. ExaVeyra Sciences is a supplier and takes no part in any diagnosis, treatment decision, or plan of care. Findings described are attributed to the peer-reviewed literature, trial registries and agencies cited. The content of these guides is provided for general informational purposes only. It does not constitute legal, medical, or regulatory advice, and does not establish that any particular product or practice is compliant. Regulatory requirements vary by state and depend on the circumstances of each practice. Each practitioner should consult their own legal counsel and the applicable state licensing boards before acting on anything stated here.

References

1.Viswanathan S, Shi Y, Galipeau J, Krampera M, Leblanc K, Martin I, et al. Mesenchymal stem versus stromal cells: International Society for Cell & Gene Therapy (ISCT®) Mesenchymal Stromal Cell committee position statement on nomenclature. Cytotherapy. 2019;21(10):1019-1024. PMID 31526643. doi:10.1016/j.jcyt.2019.08.002ISCT MSC committee position statement. Carries in this article: the committee’s recommendation that the acronym MSC be qualified by tissue of origin and that the term mesenchymal stromal cell be used unless stemness is shown by rigorous in vivo evidence, with the functional definition built on the 2006 minimal criteria and a matrix of assays. Disclosure: ISCT committee authors.
2.Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, et al. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315-7. PMID 16923606. doi:10.1080/14653240600855905ISCT position statement. Carries in this article: the three minimal criteria, plastic adherence in standard culture, expression of CD105, CD73 and CD90 with absence of CD45, CD34, CD14 or CD11b, CD79alpha or CD19 and HLA-DR, and differentiation to osteoblasts, adipocytes and chondroblasts in vitro. Disclosure: ISCT committee authors.
3.Galipeau J, Sensébé L. Mesenchymal Stromal Cells: Clinical Challenges and Therapeutic Opportunities. Cell Stem Cell. 2018;22(6):824-833. PMID 29859173. PMC6434696. doi:10.1016/j.stem.2018.05.004Perspective review. Carries in this article: the authors reported that advanced MSC trials have fallen short of the expectations raised by animal data, and traced the gap to biological and pharmacological disparities between preclinical and human studies, including tissue source, culture and cryopreservation. Disclosure: academic authors (Emory and the French blood establishment).
4.Kern S, Eichler H, Stoeve J, Klüter H, Bieback K. Comparative analysis of mesenchymal stem cells from bone marrow, umbilical cord blood, or adipose tissue. Stem Cells. 2006;24(5):1294-301. PMID 16410387. doi:10.1634/stemcells.2005-0342Laboratory comparison of MSCs from three sources. Carries in this article: isolation succeeded in 100 percent of bone marrow and adipose samples and 63 percent of cord blood samples, colony frequency was highest in adipose tissue and lowest in cord blood, cord blood cells could be cultured longest with the highest proliferation, and cord blood MSCs showed no adipogenic differentiation. Disclosure: academic transfusion medicine authors (Mannheim).
5.Jin HJ, Bae YK, Kim M, Kwon SJ, Jeon HB, Choi SJ, et al. Comparative analysis of human mesenchymal stem cells from bone marrow, adipose tissue, and umbilical cord blood as sources of cell therapy. Int J Mol Sci. 2013;14(9):17986-8001. PMID 24005862. PMC3794764. doi:10.3390/ijms140917986Laboratory comparison of human MSCs from three sources. Carries in this article: surface antigen expression, immunosuppressive activity and differentiation were similar across sources, while cord blood MSCs had the highest proliferation rate and clonality and lower expression of the senescence markers p53, p21 and p16. Disclosure: authors affiliated with a cell therapy company (MEDIPOST), as the record states.
6.Secunda R, Vennila R, Mohanashankar AM, Rajasundari M, Jeswanth S, Surendran R. Isolation, expansion and characterisation of mesenchymal stem cells from human bone marrow, adipose tissue, umbilical cord blood and matrix: a comparative study. Cytotechnology. 2015;67(5):793-807. PMID 24798808. PMC4545441. doi:10.1007/s10616-014-9718-zLaboratory comparison of four sources, including Wharton’s jelly isolated by enzymatic and explant methods. Carries in this article: the authors reported that Wharton’s jelly outperformed cord blood in rapidity, yield and ease of procedure, and that marrow and adipose collection is invasive. Disclosure: academic authors (Chennai).
7.Hass R, Kasper C, Böhm S, Jacobs R. Different populations and sources of human mesenchymal stem cells (MSC): A comparison of adult and neonatal tissue-derived MSC. Cell Commun Signal. 2011;9:12. PMID 21569606. PMC3117820. doi:10.1186/1478-811X-9-12Mini-review comparing adult sources (adipose, peripheral blood, bone marrow) with neonatal sources (placenta and umbilical cord). Carries in this article: MSCs sit in perivascular niches in nearly all tissues, and the extracellular milieu of each tissue shapes the proliferative capacity, surface markers and immunomodulatory function of the cells isolated from it. Disclosure: academic authors (Hannover).
8.Strioga M, Viswanathan S, Darinskas A, Slaby O, Michalek J. Same or not the same? Comparison of adipose tissue-derived versus bone marrow-derived mesenchymal stem and stromal cells. Stem Cells Dev. 2012;21(14):2724-52. PMID 22468918. doi:10.1089/scd.2011.0722Narrative review. Carries in this article: adipose-derived cells are isolated more easily and in larger amounts than marrow-derived cells and share most characteristics with them, with differences in immunophenotype, differentiation potential, transcriptome, proteome and immunomodulatory activity, some of which the authors attributed to isolation and culture protocols. Disclosure: academic authors.
9.Siegel G, Kluba T, Hermanutz-Klein U, Bieback K, Northoff H, Schäfer R. Phenotype, donor age and gender affect function of human bone marrow-derived mesenchymal stromal cells. BMC Med. 2013;11:146. PMID 23758701. PMC3694028. doi:10.1186/1741-7015-11-146Laboratory study of bone marrow MSCs from 53 donors aged 13 to 80. Carries in this article: cells from younger donors expressed more MCAM, VCAM-1, ALCAM, PDGFRβ and other markers and produced less IL-6 with activated T cells, high-clonogenic cells were more frequent in younger female donors, and mesodermal differentiation was unaffected by donor age or sex. Disclosure: academic authors (Tübingen and Mannheim).
10.Moll G, Alm JJ, Davies LC, von Bahr L, Heldring N, Stenbeck-Funke L, et al. Do cryopreserved mesenchymal stromal cells display impaired immunomodulatory and therapeutic properties? Stem Cells. 2014;32(9):2430-42. PMID 24805247. PMC4381870. doi:10.1002/stem.1729Laboratory comparison of freeze-thawed and freshly harvested MSCs with a clinical response analysis. Carries in this article: freeze-thawed cells showed impaired immunomodulatory and blood regulatory properties and stronger complement activation than fresh cells, which is why a tissue bank’s post-thaw viability figure and thaw instructions belong in the documentation. Disclosure: academic authors (Karolinska).
11.Soder RP, Dawn B, Weiss ML, Dunavin N, Weir S, Mitchell J, et al. A Phase I Study to Evaluate Two Doses of Wharton’s Jelly-Derived Mesenchymal Stromal Cells for the Treatment of De Novo High-Risk or Steroid-Refractory Acute Graft Versus Host Disease. Stem Cell Rev Rep. 2020;16(5):979-991. PMID 32740891. PMC9289888. doi:10.1007/s12015-020-10015-8Phase I two-cohort trial under an IND; 10 patients after allogeneic transplantation, with GMP isolation, expansion and cryostorage of the cells. Carries in this article: the trial reported no infusion-related toxicity, no related adverse events to day 42 and no ectopic tissue at day 90, and an overall response of 70 percent at day 28, the registered investigational context in which Wharton’s jelly cells appear on this site. Disclosure: investigator-initiated academic trial (Kansas).
12.Kurtzberg J, Abdel-Azim H, Carpenter P, Chaudhury S, Horn B, Mahadeo K, et al. A Phase 3, Single-Arm, Prospective Study of Remestemcel-L, Ex Vivo Culture-Expanded Adult Human Mesenchymal Stromal Cells for the Treatment of Pediatric Patients Who Failed to Respond to Steroid Treatment for Acute Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2020;26(5):845-854. PMID 32018062. PMC8322819. doi:10.1016/j.bbmt.2020.01.018Phase 3 single-arm multicenter study (NCT02336230); 54 children. Carries in this article: the bone marrow source behind the one culture-expanded MSC product with a US license, with a reported day 28 overall response of 70.4 percent against a prespecified control of 45 percent. Disclosure: sponsored by the product’s manufacturer, as the trial record states.
13.Le Blanc K, Dazzi F, English K, Farge D, Galipeau J, Horwitz EM, et al. ISCT MSC committee statement on the US FDA approval of allogenic bone-marrow mesenchymal stromal cells. Cytotherapy. 2025;27(4):413-416. PMID 39864015. doi:10.1016/j.jcyt.2025.01.005ISCT MSC committee statement. Carries in this article: the committee’s reading of the December 2024 approval as the first US license for a culture-expanded allogeneic bone marrow MSC product. Disclosure: several authors report industry relationships in the journal record.
14.Turner L, Wang JC, Martinez JR Jr, Najjar S, Rajapaksha Arachchilage T, Sahrai V. US businesses engaged in direct-to-consumer marketing of perinatal stem cell interventions following the Food and Drug Administration’s enforcement discretion era. Cytotherapy. 2024;26(4):393-403. PMID 38340106. doi:10.1016/j.jcyt.2024.01.001Data mining and content analysis of 300 US business websites selling allogeneic perinatal cell products. Carries in this article: the perinatal sources (cord blood, cord tissue, Wharton’s jelly, placenta, amniotic fluid) dominate the direct-to-consumer marketplace, and the study cataloged the brand names and suppliers involved. Disclosure: academic authors.
15.Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, et al. Multilineage potential of adult human mesenchymal stem cells. Science. 1999;284(5411):143-7. PMID 10102814. doi:10.1126/science.284.5411.143Landmark laboratory paper. Carries in this article: the demonstration that adult human bone marrow contains cells that expand in culture and differentiate to bone, cartilage and fat lineages, the origin of the bone marrow source and of the three-lineage criterion. Disclosure: industry authors (Osiris Therapeutics).
16.Thomson JA, Itskovitz-Eldor J, Shapiro SS, Waknitz MA, Swiergiel JJ, Marshall VS, et al. Embryonic stem cell lines derived from human blastocysts. Science. 1998;282(5391):1145-7. PMID 9804556. doi:10.1126/science.282.5391.1145Landmark derivation paper. Carries in this article: the first human embryonic stem cell lines, derived from blastocysts produced by in vitro fertilization, the pluripotent research source that sits outside any tissue bank catalog. Disclosure: academic authors (Wisconsin).
17.Takahashi K, Tanabe K, Ohnuki M, Narita M, Ichisaka T, Tomoda K, et al. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell. 2007;131(5):861-72. PMID 18035408. doi:10.1016/j.cell.2007.11.019Landmark derivation paper. Carries in this article: human induced pluripotent stem cells made from adult fibroblasts with four defined factors, the second pluripotent research source. Disclosure: academic authors (Kyoto).
18.Gronthos S, Mankani M, Brahim J, Robey PG, Shi S. Postnatal human dental pulp stem cells (DPSCs) in vitro and in vivo. Proc Natl Acad Sci U S A. 2000;97(25):13625-30. PMID 11087820. PMC17626. doi:10.1073/pnas.240309797Landmark derivation paper. Carries in this article: the isolation of clonogenic, highly proliferative cells from adult human dental pulp that formed dentin-like tissue in vivo, the dental pulp source. Disclosure: NIH intramural authors.
19.De Coppi P, Bartsch G Jr, Siddiqui MM, Xu T, Santos CC, Perin L, et al. Isolation of amniotic stem cell lines with potential for therapy. Nat Biotechnol. 2007;25(1):100-6. PMID 17206138. doi:10.1038/nbt1274Landmark derivation paper. Carries in this article: the isolation of broadly multipotent stem cell lines from human amniotic fluid, the amniotic fluid source. Disclosure: academic authors (Wake Forest and Harvard).
20.U.S. Food and Drug Administration. Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. July 22, 2020; content current as of 04/09/2024; verified 4 November 2026. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomesAgency consumer alert (CBER). Carries in this article: the FDA states that the only approved stem cell products consist of blood-forming stem cells derived from umbilical cord blood, names products derived from adipose tissue, cord blood, Wharton’s jelly and amniotic fluid as widely promoted and unapproved, and states that there are no FDA-approved exosome products.
21.U.S. Food and Drug Administration. RYONCIL (remestemcel-L-rknd), STN 125706, Mesoblast, Inc. Approval letter December 18, 2024; content current as of 01/17/2025; verified 4 November 2026. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/ryoncilAgency product page. Carries in this article: the FDA lists the indication as steroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older, the one licensed culture-expanded MSC product, which is derived from adult bone marrow.
22.U.S. Food and Drug Administration. HEMACORD (HPC, Cord Blood), STN BL 125397, New York Blood Center, Inc. Content current as of 04/24/2019; verified 4 November 2026. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/hemacord-hpc-cord-bloodAgency product page for the first licensed cord blood product. Carries in this article: the FDA lists the indication as unrelated donor hematopoietic progenitor cell transplantation for hematopoietic and immunologic reconstitution, which shows that the licensed cord blood products are hematopoietic cells, a cell type distinct from mesenchymal cells.
23.U.S. Food and Drug Administration. 21 CFR 1271.3, How does FDA define important terms in this part? eCFR current text and accessdata.fda.gov CFR search, verified 4 November 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.3 and https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-A/section-1271.3Federal regulation, definitions. Carries in this article: minimal manipulation for cells or nonstructural tissues means processing that does not alter the relevant biological characteristics of the cells, and the definition of an HCT/P as an article containing or consisting of human cells or tissues intended for implantation, transplantation, infusion or transfer.
24.U.S. Food and Drug Administration. 21 CFR 1271.75, How do I screen a donor? eCFR current text and accessdata.fda.gov CFR search, verified 4 November 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.75 and https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-C/section-1271.75Federal regulation, donor screening. Carries in this article: the establishment must review the donor’s relevant medical records for risk factors for and clinical evidence of HIV, hepatitis B, hepatitis C, human transmissible spongiform encephalopathy and Treponema pallidum, and for donors of viable leukocyte-rich cells, human T-lymphotropic virus.
25.U.S. Food and Drug Administration. 21 CFR 1271.80, What are the general requirements for donor testing? eCFR current text and accessdata.fda.gov CFR search, verified 4 November 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.80 and https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-C/section-1271.80Federal regulation, general donor testing requirements. Carries in this article: for a donor one month of age or younger, the establishment tests a specimen from the birth mother instead of the donor, the provision that governs every umbilical cord and placental donation, and the specimen is collected at recovery or within seven days of it.
26.U.S. Food and Drug Administration. 21 CFR 1271.85, What donor testing is required for different types of cells and tissues? eCFR current text and accessdata.fda.gov CFR search, verified 4 November 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.85 and https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-C/section-1271.85Federal regulation, donor testing. Carries in this article: a specimen from every donor is tested for HIV-1, HIV-2, hepatitis B virus, hepatitis C virus and Treponema pallidum, and donors of viable leukocyte-rich cells are also tested for HTLV-I, HTLV-II and cytomegalovirus, the serology record a tissue bank files with each lot.
27.U.S. Food and Drug Administration. Approved Cellular and Gene Therapy Products. Content current as of October 30, 2026; verified 5 November 2026. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-productsAgency list of licensed cellular and gene therapy products. Carries in this article: the list names nine licensed HPC, Cord Blood products, OMISIRGE (a cord blood derived product), gene-modified autologous hematopoietic stem cell products including CASGEVY, ZYNTEGLO, LYFGENIA, SKYSONA and LENMELDY, and RYONCIL, the only licensed MSC product, which updates the 2020 consumer alert sentence on approved stem cell products.

Frequently Asked Questions

Where do stem cells come from?: From adult bone marrow and adipose tissue, from perinatal tissues collected at birth (cord blood, cord tissue, placenta and amniotic fluid), from dental pulp, and in research from embryonic and induced pluripotent lines [15, 16, 17, 18, 19]. Kern and colleagues reported isolation success of 100 percent from marrow and adipose samples and 63 percent from cord blood [4].
What are mesenchymal stem cells?: Cells that meet the ISCT minimal criteria of Dominici and colleagues: adherence to plastic, expression of CD105, CD73 and CD90 without CD45, CD34, CD14 or CD11b, CD79alpha or CD19 and HLA-DR, and differentiation to bone, fat and cartilage in vitro [2]. The 2019 ISCT statement asks that the acronym be qualified by tissue of origin [1].
How do umbilical cord, bone marrow and adipose stem cells compare in the laboratory?: The laboratory comparisons report trade-offs between the sources. Kern and colleagues found isolation in 100 percent of marrow and adipose samples and 63 percent of cord blood samples, with cord blood cells proliferating most [4], and Jin and colleagues found similar markers and immunosuppressive activity across the three with lower senescence markers in cord blood cells [5]. No head-to-head clinical trial has compared sources [3].
What is Wharton’s jelly?: The gelatinous connective tissue of the umbilical cord that surrounds the cord vessels. Secunda and colleagues isolated MSCs from it by enzymatic and explant methods and reported faster isolation and higher yield than cord blood [6]. On this site Wharton’s jelly cells appear in the IND context, such as the 10-patient phase I trial reported by Soder and colleagues [11].
How are donor stem cells screened and tested?: From the standpoint of communicable disease, 21 CFR 1271 requires screening of every donor’s records and testing of a donor specimen for HIV-1 and HIV-2, hepatitis B and C and Treponema pallidum, with HTLV and cytomegalovirus added for leukocyte-rich cells [24, 26]. The FDA consumer alert states that many promoted products are illegally marketed, have not been shown to be safe or effective, and in some cases may have significant safety issues [20].
Embryonic vs adult stem cells, what is the difference?: Embryonic lines, first derived by Thomson and colleagues in 1998, are pluripotent and remain research tools [16], as do the induced pluripotent lines Takahashi and colleagues made from adult fibroblasts in 2007 [17]. Adult and perinatal stem cells are multipotent, forming a limited set of lineages, and are the only group that tissue banks supply [15].
Which stem cell source is FDA approved?: The FDA states that the only approved stem cell products are blood-forming cells from umbilical cord blood, licensed for hematopoietic reconstitution [20, 22], and in December 2024 it licensed one culture-expanded bone marrow MSC product for a single pediatric indication [21]. The current FDA list also includes gene-modified hematopoietic stem cell products made from a patient’s own cells, such as CASGEVY and ZYNTEGLO, and OMISIRGE, made from cord blood [27]. Products from adipose tissue, Wharton’s jelly and amniotic fluid are named by the agency as unapproved [20].
Does donor age affect stem cell quality?: For bone marrow it does. Siegel and colleagues studied 53 donors aged 13 to 80 and reported higher expression of several adhesion markers, less IL-6 production and more high-clonogenic cells in younger donors, with differentiation unaffected by age or sex [9]. Perinatal sources are collected at birth, which removes donor age as a variable [4].
How do I know where a tissue bank’s cells came from?: The certificate of analysis names the tissue of origin and carries the donor screening and serology record under 21 CFR 1271.75 and 1271.85, the ISCT identity panel by flow cytometry, the passage at harvest, and the post-thaw viability figure [2, 24, 26]. ExaVeyra makes the certificate, characterization panel and cold-chain records available on request for every lot.
Are umbilical cord stem cells the same as cord blood stem cells?: No. Cord blood yields hematopoietic progenitor cells, the licensed products for transplantation [22], and a minority of mesenchymal cells, with isolation succeeding in 63 percent of samples [4]. Cord tissue, including Wharton’s jelly, yields mesenchymal cells more readily [6], and the two sources are named separately on a certificate.

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