Supply for the Research Your Practice Joins or Runs
Orthopedic and PM&R practices increasingly take part in sponsor-held studies of cell-free and perinatal biologics. ExaVeyra supplies the study material and the documentation trail a sponsor and an institutional review board expect, and supplies compounded preparations through its 503A pharmacy partner for the practice’s own patients.
Characterized exosome material with a certificate of analysis for every lot, supplied to sponsor-held IND studies subject to the manufacturer’s authorization.
Wharton’s jelly material for sponsor-held IND studies and registered clinical trials. IND registration and other study documentation may be requested before supply.
Mesenchymal stem cell products from NeoScientifix, a registered tissue bank, for licensed practitioners and study teams, with registration and donor eligibility records.
Certificates of analysis, characterization data and chain-of-custody records organized by lot, ready for the trial master file.
Biologics ship frozen on dry ice by overnight shipping with a temperature record, and arrival can take 1 to 3 business days.
Dispensed by our 503A pharmacy partner on a patient-specific prescription, where the pharmacy holds a license for the destination state.
Regulatory notice
Exosome material. No exosome product is approved, cleared or licensed by the FDA for any use in humans, and statements on this site have not been evaluated by the FDA. Kimera exosome material is supplied to NPI-verified licensed practitioners for topical aesthetic use on the skin surface, including after procedures, as labeled by the manufacturer, and for laboratory research and clinical research conducted under an FDA investigational new drug application. It is not supplied for injection, infusion, inhalation, intranasal, ophthalmic or any other route into the body, and it is not intended to diagnose, treat, cure, mitigate or prevent any disease. Whether, how and in what setting it is used, and whether that use complies with scope of practice and state law, is the licensed practitioner’s responsibility. ExaVeyra Sciences is a supplier: it does not provide medical care, does not consult with patients and takes no part in clinical decisions. Research summaries describe published studies and are not claims about any product.
Human cell and tissue products. Mesenchymal stem cell material is supplied to NPI-verified licensed practitioners by a registered tissue bank operating under 21 CFR Part 1271. Establishment registration is not product approval, and ExaVeyra makes no claim that any cell or tissue product is safe or effective for any condition. Whether a product is regulated solely under section 361 of the Public Health Service Act, and whether its use complies with state law and the practitioner’s scope of practice, is a determination for the licensed practitioner and their counsel. ExaVeyra Sciences is a supplier: it does not provide medical care, does not consult with patients and takes no part in clinical decisions.
Compounded preparations. Compounded preparations are not FDA-approved, and the FDA does not verify their safety, effectiveness or quality before they are dispensed. Each preparation is compounded and dispensed by our 503A pharmacy partner, licensed by its state Board of Pharmacy, on a patient-specific prescription from a licensed prescriber; ExaVeyra Sciences does not compound, dispense or prescribe. ExaVeyra makes no claim that any preparation is safe or effective for any condition. Availability depends on the pharmacy’s license in the destination state and on whether the substance may be compounded under federal and state law. Prescribing, patient selection and scope of practice are the responsibility of the licensed prescriber. ExaVeyra Sciences is a supplier: it does not provide medical care, does not consult with patients and takes no part in clinical decisions.
Musculoskeletal biologics are a registered, evolving research field
Investigators worldwide have registered studies of exosomes, extracellular vesicles, secretomes and perinatal tissue across musculoskeletal research. Most are early phase, small and focused on safety, which is how a new class of biologic enters clinical research.
In the United States an unapproved biologic is studied under an investigational new drug application (IND) held by the study sponsor. The registry marks those studies as FDA-regulated drug studies; 4 of the studies below carry that flag, one of them run from Florida.
- registered studies listed
- 15
- US FDA-regulated drug studies
- 4
- in Phase 1 or earlier
- 8
| Study | Material studied | Area studied | Phase, participants | Status |
|---|---|---|---|---|
| NCT06361485R3 Stem Cell, United StatesFDA-regulated drug study | Umbilical cord Wharton’s jelly allograft | Lumbar pain | Phase 1, 100 participants | Recruiting |
| NCT07587047Adia Med of Winter Park, United States (Florida)FDA-regulated drug study | Umbilical cord blood-derived cells and exosomes | Chronic mechanical lower back pain | Phase 1, 100 participants | Recruiting |
| NCT06937528University of Jordan, Jordan | Extracellular vesicles, dose-finding | Advanced knee osteoarthrosis | Phase 1, 50 participants | Recruiting |
| NCT06431152Universidad de los Andes, Chile | Umbilical cord MSC small EVs, dose escalation | Knee osteoarthritis | Phase early 1, 12 participants | Status not updated |
| NCT05060107Francisco Espinoza (ExoOA-1) | MSC-derived small EVs | Moderate knee osteoarthritis | Phase 1, 10 participants | Status not updated |
| NCT06466850Isfahan University of Medical Sciences, Iran | Allogeneic MSC-derived exosomes | Knee osteoarthritis | Phase not stated, 20 participants | Recruiting |
| NCT06688318National Research and Innovation Agency (BRIN), Indonesia | Umbilical cord MSC conditioned medium (secretome) | Knee osteoarthritis | Phase 1/2, 11 participants | Active, not recruiting |
| NCT07787923Beijing Jishuitan Hospital, China | MSC-derived exosomes, dose escalation | Non-traumatic avascular necrosis of the femoral head | Phase early 1, 15 participants | Not yet recruiting |
| NCT05520125Institute of Biophysics and Cell Engineering, Belarus | MSCs enriched with extracellular vesicles | Segmental bone defects | Phase 1/2, 20 participants | Status not updated |
| NCT06463132Rion Inc., United StatesFDA-regulated drug study | Platelet-derived purified exosome product, alone and with hyaluronic acid | Knee osteoarthritis | Phase 1b, 24 participants | Status not updated |
| NCT06713902IRCCS Ospedale Galeazzi-Sant’Ambrogio, Italy | Extracellular vesicles in a fibrin gel | Cartilage lesions | Phase not stated, 51 participants | Recruiting |
| NCT04849429Dr. Himanshu Bansal Foundation, India | Autologous PRP enriched with exosomes | Degenerative disc disease with chronic low back pain | Phase 1, 30 participants | Completed |
| NCT05211986Immunis, Inc., United StatesFDA-regulated drug study | Stem cell secretome (IMM01-STEM) | Muscle atrophy with knee osteoarthritis | Phase 1/2, 13 participants | Completed |
| NCT07111325Shanghai Sixth People’s Hospital, China | iPSC-derived extracellular vesicles | Lateral epicondylitis | Phase 1/2, 24 participants | Recruiting |
| NCT05261360Eskisehir Osmangazi University, Türkiye | Synovial fluid MSC-derived exosomes | Degenerative meniscal injury | Phase 2, 30 participants | Status not updated |
Source: ClinicalTrials.gov, records read on October 4, 2026. Listing a study describes what was registered; it reports no result and makes no claim about any product.
How ExaVeyra supports this research
For sponsor-held IND studies and registered trials, ExaVeyra supplies exosome material, Wharton’s jelly material and NeoScientifix MSC products, subject to each manufacturer’s authorization, with lot documentation, chain of custody and dry-ice cold chain. IND registration and other study documentation may be requested before supply. ExaVeyra does not sponsor or hold an IND.
The IND and clinical-trial guideWhat a Study Sponsor Should Ask of a Biologic Supplier
Lot-to-lot characterization on one method
Particle concentration, size distribution and identity markers should be measured the same way on every lot, so a sponsor can compare lots inside one study. A certificate that changes method between lots cannot support that comparison.
Manufacturing and controls information
An IND carries chemistry, manufacturing and controls information about the investigational product. A supplier should be able to route a sponsor to the manufacturer for that information, or to a master file reference, before the first shipment.
Chain of custody and temperature record
Every shipment should travel with a continuous temperature record and a documented hand-off from the manufacturer to the site. A biologic that has been through an undocumented excursion is no longer the material described on its certificate.
Registration and donor eligibility for cell and tissue products
For human cell and tissue products the establishment registration under 21 CFR Part 1271 and the donor eligibility determination belong in the study file. Registration is a record of the establishment, and it is not approval of any product.
Benn Bluestein-Veyra, M.Sc. Organic Chemistry. Founder, ExaVeyra Sciences.
Two Supply Paths Under One Verified Account
An orthopedic practice that joins a sponsored study and also prescribes compounded preparations deals with two regulatory paths. ExaVeyra keeps them separate and documents each one.
Research Supply
- Exosome material for IND studies
- Wharton’s jelly for registered trials
- NeoScientifix MSC products
- Manufacturer authorization per study
- Certificate of analysis per lot, on request
- Dry-ice overnight shipping
503A Compounded Preparations
- Dispensed by our 503A pharmacy partner
- Patient-specific prescription only
- Pharmacy licensed in 33 jurisdictions
- Availability depends on the substance
- Beyond-use date on every label
- Formulary after NPI verification
Approved accounts work with a dedicated account manager who coordinates study documentation with the manufacturer and the sponsor.
What Orthopedic Accounts Order
Every line requires an NPI-verified account. Research material requires the manufacturer’s authorization for the study, and compounded preparations require a patient-specific prescription.
IND and Clinical Trial Supply
Exosome material, Wharton’s jelly and MSC products for sponsor-held IND studies and registered trials, with lot documentation for the study file.
Lot Documentation
Certificates of analysis and characterization data that a sponsor and an institutional review board can read, organized by lot.
Human Cell and Tissue Products
MSC products from NeoScientifix, a registered tissue bank, with establishment registration and donor eligibility records.
503A Compounded Preparations
Dispensed by our 503A pharmacy partner on a patient-specific prescription. The formulary opens after NPI verification.
What Orthopedic Research Teams Get From Our Supply Chain
A Chemist Reads the Documentation First
Each lot’s certificate and characterization method is reviewed before it reaches a study team, so questions are raised before enrollment rather than after.
Manufacturer Authorization Coordinated
Research supply runs under each manufacturer’s authorization for the study. We coordinate that step with the sponsor and the manufacturer.
Cold Chain That Holds
Biologics ship frozen on dry ice by overnight shipping with a temperature record, and arrival can take 1 to 3 business days.
Two Paths Kept Apart
Research material and compounded preparations follow different regulatory paths, and their records never mix.
NPI-Verified Access
Accounts open to licensed practitioners and the practices and institutions that employ them, after NPI verification in 1 to 3 business days.
One Account Manager
A dedicated account manager handles documentation requests, shipping schedules and study timelines.
Questions from Orthopedic Practices and Study Teams
Can ExaVeyra supply biologic material for an orthopedic IND study?+
Yes, subject to each manufacturer’s authorization for the study. For sponsor-held IND studies and registered trials ExaVeyra supplies exosome material, Wharton’s jelly material and NeoScientifix MSC products, with a certificate of analysis for every lot. IND registration and other study documentation may be requested before supply. ExaVeyra does not sponsor or hold an IND.
What registered research exists on exosomes and perinatal biologics in orthopedics?+
ClinicalTrials.gov lists early-phase studies of exosomes, extracellular vesicles, secretomes and Wharton’s jelly across musculoskeletal research, most of them small and focused on safety. The table on this page lists the registered studies with their phase, size, sponsor and status.
Is any exosome product FDA-approved for orthopedic use?+
No exosome product is FDA-approved for any use. In the United States they are studied under an IND held by the study sponsor. Outside an IND, ExaVeyra supplies exosome material only for topical aesthetic use by licensed practitioners.
What documentation comes with research material?+
A certificate of analysis for every lot, the characterization method behind each figure, the shipment temperature record and, for human cell and tissue products, the establishment registration and donor eligibility records. Manufacturing and controls information is requested from the manufacturer for the sponsor.
How are compounded preparations supplied to an orthopedic practice?+
Compounded preparations are dispensed by our 503A pharmacy partner on a patient-specific prescription, where the pharmacy holds a license for the destination state, and availability depends on whether the substance may be compounded under federal and state law. The formulary opens after NPI verification.
How fast does research material ship?+
Orders ship once the manufacturer’s authorization is confirmed. Biologics ship frozen on dry ice by overnight shipping, and arrival can take 1 to 3 business days.