Three different products share the name
Cord blood stem cells
Blood-forming cells from cord blood, used to rebuild a patient's blood and immune system. This is the only approved use in the US, with nine licensed products.[1][3]
Cord tissue or Wharton's jelly cells
Mesenchymal cells grown from the cord's connective tissue. This is what most private clinics inject, and it is not approved in any market this site covers.[2][1] About mesenchymal stem cells
How it is given
The product arrives frozen from a donor, is thawed and is injected into a joint or given by drip. There is no harvest from your body.[6] Patients describe a needle-only or drip-only day, and repeat rounds are common.[7]
No tissue matching is done for cord cells sold as a treatment: they are given off the shelf, without matching and without anti-rejection drugs.[8]
No better than the patient's own cells, or a steroid
Side effects
Fever is about twice as common as with control.[11] In knee trials, short-lived reactions such as swelling were far more common with donor cord cells than with your own fat cells.[12] Donor cells can trigger antibodies: 5 of 12 children given a cord tissue product made new antibodies, which can make a future organ transplant harder to match.[13] In 2018, contaminated cord products put 12 US patients in hospital with blood and joint infections.[14]
Are umbilical cord stem cells FDA approved?
Only cord blood stem cells, for rebuilding blood and immune systems. Cord tissue and Wharton's jelly products are not approved for anything, and the FDA has sent warning letters to the companies selling them.[1][15][16]
United States. A cord product used to treat a condition needs FDA approval or a clinical trial.[17]
Malaysia. Every donor cord product must be registered before a clinic can give it. None was found registered.[18]
Mexico. The health ministry says cord stem cells are approved only for children with blood diseases.[19]
South Korea. Cartistem, a cord blood cell product implanted by surgery into a knee cartilage defect, is approved.[2]
Common questions
Is this the same as the cord blood we banked at birth?
Only if the cord blood is used for a blood or immune disorder.[1][3] The American Academy of Pediatrics notes private banking is expensive, not covered by insurance, and the unit may never be used.[20]
Are donor cord cells better because they are younger?
They grow faster in a dish, but no trial has shown a benefit in patients.[21][6]
Does freezing matter?
Yes. Thawed cells release fewer anti-inflammatory signals and are cleared faster.[22]
Questions to ask a clinic
- Is this cord blood, or cells grown from cord tissue?
- Can I see the certificate of analysis for my batch before I pay?
- How many live cells are in the vial, and how was that measured?
- How was the donor screened?
- Was it frozen, and how long ago?
- Could repeat doses affect a future transplant?
Sources
22 references
- U.S. Food and Drug Administration. Approved Cellular and Gene Therapy Products. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, 2026. Link
- Fernández-Garza LE, et al. Mesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World. Pharmaceuticals (Basel, Switzerland), 2023. Link
- Zhu X, et al. Umbilical cord blood transplantation: Still growing and improving. Stem Cells Translational Medicine, 2021. Link
- Secunda R, et al. Isolation, expansion and characterisation of mesenchymal stem cells from human bone marrow, adipose tissue, umbilical cord blood and matrix: a comparative study. Cytotechnology, 2015. Link
- Montemurro T, et al. Off-the-Shelf Cord-Blood Mesenchymal Stromal Cells: Production, Quality Control, and Clinical Use. Cells, 2024. Link
- Mautner K, et al. Cell-based versus corticosteroid injections for knee pain in osteoarthritis: a randomized phase 3 trial. Nature Medicine, 2023. Link
- StemFinder review of first-hand patient accounts on Reddit and patient forums, 2026. Method
- Bartolucci J, et al. Safety and Efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Patients With Heart Failure: A Phase 1/2 Randomized Controlled Trial (RIMECARD Trial [Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy]). Circulation Research, 2017. Link
- Berger DR, et al. Colony Forming Potential and Protein Composition of Commercial Umbilical Cord Allograft Products in Comparison With Autologous Orthobiologics. The American Journal of Sports Medicine, 2021. Link
- Becktell L, et al. Proteomic Analysis and Cell Viability of Nine Amnion, Chorion, Umbilical Cord, and Amniotic Fluid-Derived Products. Cartilage, 2021. Link
- Hum C, et al. Safety of intravascular administration of umbilical-cord-derived mesenchymal stromal cells: an updated systematic review and meta-analysis. Stem Cells Translational Medicine, 2026. Link
- Riggle C, et al. Complications of Stem Cell-Based Injections for Knee Osteoarthritis: A Systematic Review. HSS journal, 2025. Link
- Sun JM, et al. Infusion of human umbilical cord tissue mesenchymal stromal cells in children with autism spectrum disorder. Stem Cells Translational Medicine, 2020. Link
- Perkins KM, et al. Notes from the Field: Infections After Receipt of Bacterially Contaminated Umbilical Cord Blood-Derived Stem Cell Products for Other Than Hematopoietic or Immunologic Reconstitution - United States, 2018. MMWR. Morbidity and Mortality Weekly Report, 2018. Link
- U.S. Food and Drug Administration. Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. 2024. Link
- U.S. Food and Drug Administration. Warning Letter: R3 Medical Companies, 726330, 08/14/2026. 2026. Link
- U.S. Food and Drug Administration. 21 CFR Part 1271, Subpart A (General Provisions): §§ 1271.3, 1271.10, 1271.15 and 1271.20. Electronic Code of Federal Regulations (eCFR), U.S. National Archives, 2026. Link
- National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia. Guidance Document and Guidelines for Registration of Cell and Gene Therapy Products (CGTPs) in Malaysia, Second Edition (September 2025). 2025. Link
- Secretaría de Salud, Gobierno de México. 318. Uso de células madre contará con marco regulatorio. Gobierno de México, Secretaría de Salud (press Release), 2018. Link
- Shearer WT, et al. Cord Blood Banking for Potential Future Transplantation. Pediatrics (American Academy of Pediatrics policy statement), 2017. Link
- Hass R, et al. Different populations and sources of human mesenchymal stem cells (MSC): A comparison of adult and neonatal tissue-derived MSC. Cell Communication and Signaling, 2011. Link
- Moll G, et al. Do cryopreserved mesenchymal stromal cells display impaired immunomodulatory and therapeutic properties? Stem cells (Dayton, Ohio), 2014. Link




