The best published price point for a stem cell injection in the United States comes from Piuzzi and colleagues, who called 273 centers as a simulated patient in 2018 and reported a mean of $5,156 for one same-day knee injection (standard deviation $2,446, 65 centers quoting a figure) [2]. Nearly all of that spending is out of pocket: the FDA states that generally all stem cell products require FDA approval [18], and the Medicare coverage determination lists hematopoietic stem cell transplantation for named blood disorders and no clinic injection.
Four cost lines sit behind every vial of a cell product: donor screening and testing, manufacturing under current good tissue practice and GMP, lot release testing, and a liquid nitrogen cold chain. The sections below then set out what the marketplace literature reports about clinic pricing, what the coverage record says, and a cost-component table a practice can complete with its own figures. 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.
Regulatory status
The FDA states that stem cell products are regulated by the agency, that generally all stem cell products require FDA approval, and that the only approved stem cell products consist of blood-forming stem cells derived from umbilical cord blood [18]; its current approved-products list also includes OMISIRGE, made from cord blood, and several gene-modified hematopoietic stem cell products [19]. One culture-expanded mesenchymal stromal cell product, remestemcel-L, received a US license on 18 December 2024 for a single pediatric indication [20]. 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.
Donor screening and testing set the first cost of any allogeneic cell product
An allogeneic cell product begins with a donor, and 21 CFR 1271 subpart C fixes what the establishment must do before that donor’s cells can be released. Under 1271.75 the establishment reviews 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 viable leukocyte-rich cells, human T-lymphotropic virus as well [23].
Under 1271.85 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 [24]. For a donor one month of age or younger, which covers every umbilical cord and placental donation, 21 CFR 1271.80 directs that the specimen come from the birth mother [27].
Each of those steps is a laboratory invoice, a records review and a qualified person’s signature, and a donor who fails screening is a cost with no product. That is the first reason a vial from a registered tissue bank carries a serology record, and the first line in any cost model.
Manufacturing under current good tissue practice and drug GMP scales with lot size
Subparts C and D of 21 CFR 1271 set the current good tissue practice requirements, which the FDA frames as the controls that keep communicable disease agents out of an HCT/P, and an HCT/P that is a drug or biologic is also subject to the drug and device GMP regulations in parts 210, 211 and 820 [25]. Sensebé and colleagues reviewed GMP production of MSCs in 2013 and reported that compliance requires a defined process, a controlled environment, trained and qualified staff, and reproducible controls, with relevant release controls among the hardest problems to solve [11].
Simaria and colleagues modeled allogeneic cell expansion economics in 2014 and reported that commercial demand can reach a billion cells per dose, that planar flasks stop being cost-effective beyond a certain scale, and that microcarrier bioreactors become the only option at the largest lot sizes [9]. Hassan and colleagues extended the model in 2015 to harvest, wash, concentration and fill, and reported that downstream processing is a cost driver in its own right whose share grows with lot size [10].
The source tissue changes the arithmetic as well. Kern and colleagues compared MSCs from bone marrow, cord blood and adipose tissue in 2006 and reported isolation success in 100 percent of marrow and adipose samples and 63 percent of cord blood samples, while cord blood cells expanded to the highest numbers [16]. A failed isolation is a donor’s worth of screening cost spread across the lots that did succeed.
Release testing adds a fixed panel to every lot
A lot of cells is released against a panel, and the panel costs the same whether the lot yields ten vials or a thousand. Identity by flow cytometry follows the International Society for Cellular Therapy minimal criteria of Dominici and colleagues: CD105, CD73 and CD90 positive, CD45, CD34, CD14 or CD11b, CD79alpha or CD19 and HLA-DR negative, together with plastic adherence and three-lineage differentiation [17].
Sterility testing of each lot of a licensed biological product is required by 21 CFR 610.12, and the same test appears on the certificate of a tissue bank product [26]. Endotoxin, mycoplasma and post-thaw viability complete the usual safety and quality lines, and the ISCT MSC committee recommended in 2016 that advanced-phase release also include a matrix of potency assays [12].
- Identity: flow cytometry against the ISCT marker panel, with the percentage positive and negative for each marker recorded on the certificate [17]
- Viability: a post-thaw count by dye exclusion or flow cytometry, the figure Florida law directs a supplier to report to the physician per lot
- Sterility: a compendial culture of the final container material for each lot [26]
- Endotoxin and mycoplasma: safety assays run on each lot before release, under the final product testing headings of the FDA’s CMC guidance for somatic cell products [28]
- Potency: an immune functional assay or a secreted-factor assay, recommended by the ISCT committee for advanced trials [12]
- Serology: the donor testing record under 1271.85, filed with the lot [24]
This is why a per-vial price falls as a lot grows and why two products with the same cell count can cost very different amounts. The certificate of analysis for a lot is the receipt for this panel, and reading it is the fastest way to see what a price includes.
The liquid nitrogen cold chain is part of the product
Cell products are stored in liquid nitrogen vapor and shipped in dry vapor shippers or on dry ice, and the literature places that chain inside manufacturing. Cottle and colleagues reviewed cryopreservation in 2022 and described freezing and thawing as among the final steps in economically viable manufacturing and as a potential weak point for product safety and efficacy [15].
The reason the chain is guarded closely is functional. François and colleagues reported in 2012 that freshly thawed cryopreserved MSCs up-regulated heat-shock proteins and were compromised in suppressing T cell proliferation, with function restored after 24 hours in culture [14]. Moll and colleagues reported in 2014 that freeze-thawed cells showed impaired immunomodulatory and blood regulatory properties and stronger complement activation than freshly harvested cells [13].
Every link in that chain has a price: controlled-rate freezers, vapor-phase storage with alarms, validated shippers, temperature loggers and the staff who read them. ExaVeyra ships cell products frozen with the lot number on every vial, and the cold-chain records for a lot are available on request alongside the certificate of analysis.
Published surveys describe what clinics charge and what the record shows
Turner and Knoepfler counted the US direct-to-consumer marketplace in 2016 [4], and Knoepfler re-examined that cohort of 570 clinic locations in 2019, reporting that about a quarter of firms had stopped marketing stem cells while the total clinic count rose because some firms expanded [5]. Turner repeated the census in March 2021 and reported 1,480 businesses operating 2,754 clinics, more than four times the number of businesses found five years earlier [1].
Piuzzi and colleagues reported in 2018 that the 65 centers quoting a price for a same-day knee injection averaged $5,156, and that centers claimed a mean 82 percent of patients had good results, a gap the authors described between marketing and the published literature [2]. Turner and colleagues analyzed 300 businesses selling allogeneic perinatal cell products in 2024, after the end of FDA enforcement discretion, and cataloged the prices charged, the brand names and the suppliers involved [3].
A quoted price for a cell product is the sum of a donor, a manufacturing lot, a release panel and a cold chain, divided by the vials that lot produced. The certificate of analysis shows which of those lines the price actually covers.
Several cost questions remain open in the published evidence
A practice pricing a cell-based service should know which figures exist and which do not. The points below set out what the published evidence does not yet show.
- Manufacturing cost per vial is unpublished for commercial tissue bank products: the bioprocess models of Simaria and Hassan describe cost drivers and scale effects, and name no commercial price [9, 10].
- The marketplace prices are survey snapshots: Piuzzi’s $5,156 figure dates from 2018 and covers knee injections only [2], and the 2024 perinatal price catalog describes a marketplace that Knoepfler showed changes quickly [3, 5].
- Price and quality are not linked in any published dataset: no study has compared the certificate of analysis contents of marketed products against the prices charged.
- Fresh and thawed cells differ in the laboratory, and the clinical size of that difference remains under study: Moll reported a trend toward better response with fresh low-passage cells, which the authors did not present as settled [13].
- Cost-effectiveness data exist for transplant uses: the Ramsey analysis compared two transplant strategies and reports an incremental cost of $118,953, with no figure for clinic injections [8].
- Insurer policies vary: the Medicare coverage determination is public, and commercial policies are published by each carrier, outside the peer-reviewed literature.
Coverage follows listed transplant indications, which sets the out-of-pocket frame
The FDA consumer alert of 2020 states that the only approved stem cell products are blood-forming stem cells derived from umbilical cord blood, approved for disorders affecting the hematopoietic system and not for other uses [18]. The agency’s current approved-products list names HEMACORD among nine licensed HPC, Cord Blood products, OMISIRGE, several gene-modified hematopoietic stem cell products such as CASGEVY and ZYNTEGLO, and RYONCIL, the only licensed MSC product [19, 21].
Medicare coverage is set by indication. The CMS national coverage determination 110.23, Stem Cell Transplantation, covers allogeneic hematopoietic stem cell transplantation using bone marrow, peripheral blood or umbilical cord blood for listed hematologic indications, with its current version effective 6 March 2024 (https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=366, verified 4 November 2026). Ramsey and colleagues estimated in 2023, from 368 randomized patients, that haploidentical marrow transplantation costs $118,953 more than double cord blood transplantation over 20 years in patients under 65 [8].
The remestemcel-L license of December 2024 rests on a phase 3 single-arm study in 54 children, in which Kurtzberg and colleagues reported a day 28 overall response of 70.4 percent against a prespecified control of 45 percent [6, 20]. The ISCT MSC committee read that approval in 2025 as the first US license for a culture-expanded allogeneic bone marrow MSC product and pointed to manufacturing consistency and potency as the route to further approvals [7]. Outside those approved uses, the FDA notes that an IND is the route for a cell product that is a drug, and after 31 May 2021 the agency no longer exercises enforcement discretion on that requirement [22].
A cost-component table a practice can complete with its own figures
The table lists the lines that make up the cost of offering a cell product, the source behind each, and where a practice finds its own number. ExaVeyra publishes no prices in this article; a verified account sees pricing for each available format, and the practice sets its own fees.
| Cost line | What drives it | Where the figure comes from |
|---|---|---|
| Cell product | Format, cell count per vial and lot size; the release panel is fixed per lot [12, 17, 26] | Supplier quote for a verified account |
| Documentation review | Time to read the certificate of analysis, serology and characterization panel per lot [23, 24] | Clinical lead payroll |
| Cold storage | Vapor-phase liquid nitrogen or validated freezer, alarms, logger and a backup plan [15] | Equipment and service quotes |
| Receiving and thaw | Dry ice check, arrival time, thaw procedure and the window to use after thaw [13, 14] | Manufacturer handling instructions |
| Regulatory pathway | IND sponsorship or trial participation where a product is a drug [22] | Counsel and the IRB |
| State requirements | Notice, consent and reporting duties in the states that permit the service | State statute and counsel |
| Session time | Practitioner and staff minutes for the procedure and charting | Booking template |
| Consent and records | Consent drafting, legal review and a session record carrying the lot number | Counsel and practice manager |
| Insurance | Policy review to confirm the service is covered by the practice’s carrier | The practice’s carrier |
| Wastage | Thawed material not used within the handling window and any storage excursion | Receiving and storage logs |
A verified account turns the cost model into a documented service
A practice that prices a cell-based service from the table above starts with a product it can document: a lot number on every vial, a certificate of analysis for every lot with serology, and the characterization panel and cold-chain records available on request. 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 build their cost model on documented lots are well placed to grow the service as the evidence and the approvals mature.
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.Turner L. The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions. Cell Stem Cell. 2021;28(11):1891-1895. PMID 34739831. doi:10.1016/j.stem.2021.10.008Systematic census of US business websites, March 2021. Carries in this article: 1,480 US businesses operating 2,754 clinics were selling purported stem cell interventions that were not FDA approved, more than four times the number of businesses found five years earlier. Disclosure: academic author (University of California, Irvine); no funding statement in the PubMed record.
- 2.Piuzzi NS, Ng M, Chughtai M, Khlopas A, Ng K, Mont MA, et al. The Stem-Cell Market for the Treatment of Knee Osteoarthritis: A Patient Perspective. J Knee Surg. 2018;31(6):551-556. PMID 28738432. doi:10.1055/s-0037-1604443Prospective cross-sectional simulated-patient survey; 273 of 317 US centers contacted by phone or email. Carries in this article: the mean marketed price of one same-day knee injection was $5,156 (SD $2,446; 95% CI $4,550 to $5,762; n = 65 centers quoting a price), and centers claimed a mean 82 percent of patients had good results, a gap the authors reported between marketing and the published literature. Disclosure: orthopedic academic authors; no funding statement in the PubMed record.
- 3.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, conducted after the end of FDA enforcement discretion. Carries in this article: the study cataloged the product types, clinic locations, prices charged, brand names and suppliers of perinatal cell products sold direct to consumers. Disclosure: academic authors; no funding statement in the PubMed record.
- 4.Turner L, Knoepfler P. Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry. Cell Stem Cell. 2016;19(2):154-157. PMID 27374789. doi:10.1016/j.stem.2016.06.007Internet-based census of US businesses marketing stem cell interventions, 2015 to 2016; the cohort of 570 clinic locations that Knoepfler re-examined in 2019 [5]. Carries in this article: the first systematic count of the US direct-to-consumer marketplace and the baseline against which the 2021 census is compared. Disclosure: academic authors (Minnesota and UC Davis).
- 5.Knoepfler PS. Rapid change of a cohort of 570 unproven stem cell clinics in the USA over 3 years. Regen Med. 2019;14(8):735-740. PMID 31456478. doi:10.2217/rme-2019-0064Follow-up of the 2015 to 2016 cohort of US clinic firms in 2019. Carries in this article: about a quarter of the firms no longer marketed stem cells, yet the total clinic count in the cohort rose because some firms expanded, the reason the author described the marketplace as a moving target. Disclosure: academic author (UC Davis).
- 6.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 day 28 overall response rate the trial reported was 70.4 percent against a prespecified control of 45 percent, and survival was 74.1 percent at day 100, the evidence package behind the 2024 approval of the product [20]. Disclosure: sponsored by the product’s manufacturer, as the trial record states.
- 7.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.2025.01.005Position statement of the International Society for Cell and Gene Therapy MSC committee. 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, and its emphasis on manufacturing consistency and potency as the route to further approvals. Disclosure: several authors report industry relationships in the journal record.
- 8.Ramsey SD, Bansal A, Li L, O’Donnell PV, Fuchs EJ, Brunstein CG, et al. Cost-Effectiveness of Unrelated Umbilical Cord Blood Transplantation versus HLA-Haploidentical Related Bone Marrow Transplantation: Evidence from BMT CTN 1101. Transplant Cell Ther. 2023;29(7):464.e1-464.e8. PMID 37120135. PMC10353308. doi:10.1016/j.jtct.2023.04.017Cost-effectiveness analysis alongside a phase III randomized trial; 368 patients (186 cord blood, 182 haploidentical marrow), with costs from commercial claims and Medicare claims. Carries in this article: an incremental cost, with haploidentical marrow transplantation expected to cost $118,953 more than double cord blood transplantation over 20 years in patients under 65; the abstract reports no total episode cost. Disclosure: NIH-funded trial network.
- 9.Simaria AS, Hassan S, Varadaraju H, Rowley J, Warren K, Vanek P, et al. Allogeneic cell therapy bioprocess economics and optimization: single-use cell expansion technologies. Biotechnol Bioeng. 2014;111(1):69-83. PMID 23893544. PMC4065358. doi:10.1002/bit.25008Bioprocess economics model of allogeneic cell expansion. Carries in this article: commercial lot sizes of up to a billion cells per dose, the production scales at which planar flasks stop being cost-effective and microcarrier bioreactors become the only option, and the authors’ finding that the field needs large gains in bioreactor performance to be sustainable. Disclosure: industry co-authors (Lonza) and academic authors (UCL).
- 10.Hassan S, Simaria AS, Varadaraju H, Gupta S, Warren K, Farid SS. Allogeneic cell therapy bioprocess economics and optimization: downstream processing decisions. Regen Med. 2015;10(5):591-609. PMID 26237703. doi:10.2217/rme.15.29Companion bioprocess economics analysis of harvest, wash, concentration and fill steps for allogeneic cell products. Carries in this article: downstream processing is a cost driver in its own right, separate from expansion, and its share grows with lot size. Disclosure: industry and academic authors.
- 11.Sensebé L, Gadelorge M, Fleury-Cappellesso S. Production of mesenchymal stromal/stem cells according to good manufacturing practices: a review. Stem Cell Res Ther. 2013;4(3):66. PMID 23751270. PMC3707032. doi:10.1186/scrt217Narrative review of GMP production of MSCs. Carries in this article: GMP compliance requires a defined process, a controlled environment, trained and qualified staff, and reproducible controls for safety and efficacy, and the authors reported that relevant release controls remain one of the hardest problems. Disclosure: French blood establishment authors.
- 12.Galipeau J, Krampera M, Barrett J, Dazzi F, Deans RJ, DeBruijn J, et al. International Society for Cellular Therapy perspective on immune functional assays for mesenchymal stromal cells as potency release criterion for advanced phase clinical trials. Cytotherapy. 2016;18(2):151-9. PMID 26724220. PMC4745114. doi:10.1016/j.jcyt.2015.11.008ISCT MSC committee perspective. Carries in this article: release of an MSC lot for advanced trials should include a matrix of potency assays in addition to identity and safety testing, which is why a potency test is a cost line in a lot release panel. Disclosure: ISCT committee authors, including an industry co-author.
- 13.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, the reason post-thaw viability and recovery figures matter on a certificate. Disclosure: academic authors (Karolinska).
- 14.François M, Copland IB, Yuan S, Romieu-Mourez R, Waller EK, Galipeau J. Cryopreserved mesenchymal stromal cells display impaired immunosuppressive properties as a result of heat-shock response and impaired interferon-γ licensing. Cytotherapy. 2012;14(2):147-52. PMID 22029655. PMC3279133. doi:10.3109/14653249.2011.623691Laboratory study of freshly thawed cryopreserved human MSCs. Carries in this article: thawed cells up-regulated heat-shock proteins and were compromised in suppressing T cell proliferation, with function restored after 24 hours of culture, the mechanistic basis for the handling instructions a tissue bank supplies. Disclosure: academic authors (Emory).
- 15.Cottle C, Porter AP, Lipat A, Turner-Lyles C, Nguyen J, Moll G, et al. Impact of Cryopreservation and Freeze-Thawing on Therapeutic Properties of Mesenchymal Stromal/Stem Cells and Other Common Cellular Therapeutics. Curr Stem Cell Rep. 2022;8(2):72-92. PMID 35502223. PMC9045030. doi:10.1007/s40778-022-00212-1Narrative review. Carries in this article: the authors described cryopreservation and thawing as among the final steps in economically viable manufacturing of cell products, and as a potential weak point for product safety and efficacy, which places the cold chain inside the cost model. Disclosure: academic authors.
- 16.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, while cord blood cells expanded to the highest numbers, the yield differences that feed into a per-vial cost. Disclosure: academic transfusion medicine authors (Mannheim).
- 17.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 identity panel a release test measures by flow cytometry, CD105, CD73 and CD90 positive and CD45, CD34, CD14 or CD11b, CD79alpha or CD19 and HLA-DR negative, plus plastic adherence and three-lineage differentiation. Disclosure: ISCT committee authors.
- 18.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 generally all stem cell products require FDA approval and that the only approved stem cell products consist of blood-forming stem cells derived from umbilical cord blood, approved for disorders affecting the hematopoietic system and not for other uses, and that there are no FDA-approved exosome products.
- 19.U.S. Food and Drug Administration. Approved Cellular and Gene Therapy Products. Content current as of 10/30/2026; verified 4 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 (HEMACORD among them), OMISIRGE (a cord blood derived product), gene-modified autologous hematopoietic stem cell products including CASGEVY and ZYNTEGLO, and RYONCIL, the only licensed MSC product.
- 20.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 culture-expanded MSC product with a US license, which sets the reference point for what an approved cell product costs to bring to market.
- 21.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 in disorders affecting the hematopoietic system, the product class Medicare coverage and the consumer alert both refer to.
- 22.U.S. Food and Drug Administration. Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular or Tissue-based Products (HCT/Ps). Content current as of 07/09/2021; verified 4 November 2026. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/questions-and-answers-regarding-end-compliance-and-enforcement-policy-certain-human-cells-tissues-orAgency questions and answers page (CBER). Carries in this article: after May 31, 2021, the FDA no longer intends to exercise enforcement discretion with respect to the IND and premarket approval requirements for HCT/Ps that do not meet the 361 criteria, which is why an IND or a license sits in the cost model of any cell product that is a drug.
- 23.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 as well.
- 24.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 must be tested for HIV-1, HIV-2, hepatitis B virus, hepatitis C virus and Treponema pallidum, and donors of viable leukocyte-rich cells must also be tested for HTLV-I, HTLV-II and cytomegalovirus; under 1271.80 a donor one month of age or younger is tested through a specimen from the birth mother.
- 25.U.S. Food and Drug Administration. 21 CFR 1271.150, Current good tissue practice requirements. 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=1271.150 and https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271/subpart-D/section-1271.150Federal regulation, current good tissue practice. Carries in this article: subparts C and D set the CGTP requirements the FDA frames as the controls that keep communicable disease agents out of HCT/Ps, and HCT/Ps that are drugs or biologics are also subject to the drug and device GMP regulations in parts 210, 211 and 820.
- 26.U.S. Food and Drug Administration. 21 CFR 610.12, Sterility (General Biological Products Standards). 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=610.12 and https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-610/subpart-B/section-610.12Federal regulation, sterility testing of biological products. Carries in this article: manufacturers of licensed biological products must perform sterility testing of each lot of final container material, the per-lot test that appears as a line on any cell product certificate of analysis.
- 27.U.S. Food and Drug Administration. 21 CFR 1271.80, What are the general requirements for donor testing? eCFR current text, verified 5 November 2026. 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, with the specimen collected at recovery or up to 7 days before or after it.
- 28.U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs). Guidance for FDA Reviewers and Sponsors, April 2008, docket FDA-2008-D-0206; verified 5 November 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-and-review-chemistry-manufacturing-and-control-cmc-information-human-somatic-cell-therapyAgency guidance. Carries in this article: the final product testing headings for a cell product, which are microbiological testing (sterility, mycoplasma and adventitious agents), identity, purity (residual contaminants and pyrogenicity or endotoxin), potency and viability, the source of the endotoxin and mycoplasma lines on a lot release panel.