Stem cell therapy for spinal cord injury.

Clinics inject cells into the spinal fluid to restore movement and feeling after a spinal cord injury. After more than 20 years of trials, sensation and bladder function may improve slightly, and movement does not.[1][2]

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What to expect

The procedure

Cells from bone marrow, fat or donor umbilical cord are usually injected into the spinal fluid through a needle in the lower back, sometimes with a drip as well.[3][4] The usual clinic trip is two to four days, and nobody in our review was kept overnight for the injection itself.[5]

How many sessions

Almost every trial gave one dose. The one trial that gave two, three months apart, found no difference from placebo.[4][3][6]

When it works, and how long it lasts

Where trials found any gain, it was in sensation, and it was measured over a year. No treatment improved movement at 12 months in the pooled data.[7]

Who it suits, and who it doesn't

Pooled studies disagree on whether early or late treatment does better, and none has tested it properly.[8] Researchers warn that an unregulated injection can rule you out of a proper trial later.[5]

Risks

About one person in five has a side effect, usually a few days of headache, back pain, fever or neck stiffness.[9][10] Serious harms outside trials include meningitis in five of seven people who paid for spinal surgery abroad.[11] Patients were told headache, fever and vomiting after a spinal injection were normal, and in two of three accounts it was an infection or nerve damage.[5]

Sensation and bladder may improve a little; movement does not

Does it work? After more than 20 years and 1,600 treated people, no trial has produced a repeatable improvement in movement.[9][2] Small, mostly open trials show a consistent signal for sensation and bladder function.[1][10]

No differencefrom placebo on any measure at 12 months, after two doses in chronic incomplete neck injuryPlacebo-controlled trial, 18 people[6]
Pinprick onlyimproved after one cord-cell dose in chronic complete injury; nothing else changedPlacebo-controlled trial, 10 people[3]
About 30%of people improve an injury grade in the first year with no treatment at all, which is why uncontrolled results misleadNatural recovery data[12]
0 of 32people who described clinic or trial treatment online went from a complete injury to walkingOur review of patient accounts on Reddit and forums[5]

Where it is allowed

United States. No cell product is approved for spinal cord injury.[13] The FDA has warned a clinic that claimed its cord product helped spinal cord injury.[14]

Malaysia. Every product used in these studies, except your own same-day bone marrow cells, must be registered first.[15]

Mexico. COFEPRIS has said stem cell treatments lack authorisation.[16]

Japan. Stemirac has a conditional, time-limited approval based on 13 patients with no comparison group. It must still prove that it works.[17][18]

Common questions

Can it get me walking again?

No controlled study has shown it.[2][8]

What does Japan's approval of Stemirac mean?

It is conditional and must be confirmed within a set period. The first product approved that way, a heart treatment, was later refused full approval when it failed to show a benefit.[19]

Do exosomes work?

One nine-person study with no comparison group exists. No exosome product is approved anywhere.[20][21]

Questions to ask a clinic

  1. Have you treated anyone with a complete injury like mine who can now walk? Can I speak to them?
  2. Will this rule me out of a clinical trial later?
  3. Is it a spinal injection or a drip? How will the cells reach my spinal cord?
  4. Which cells, and can I see the certificate for my batch?
  5. What symptoms afterwards mean I need a doctor straight away?
  6. What rehabilitation is included, and could that explain any gain?

Sources

21 references
  1. Muthu S, et al. Current evidence on mesenchymal stem cell therapy for traumatic spinal cord injury: systematic review and meta-analysis. Cytotherapy, 2021. Link
  2. Zipser CM, et al. Cell-based and stem-cell-based treatments for spinal cord injury: evidence from clinical trials. The Lancet. Neurology, 2022. Link
  3. Albu S, et al. Clinical effects of intrathecal administration of expanded Wharton jelly mesenchymal stromal cells in patients with chronic complete spinal cord injury: a randomized controlled study. Cytotherapy, 2021. Link
  4. Bydon M, et al. Intrathecal delivery of adipose-derived mesenchymal stem cells in traumatic spinal cord injury: Phase I trial. Nature Communications, 2024. Link
  5. StemFinder review of first-hand patient accounts on Reddit and patient forums, 2026. Method
  6. Martins Braga F, et al. Mesenchymal Stromal/Stem Cells in Chronic Incomplete Traumatic Spinal Cord Injury: A Phase I/II Double-Blind Placebo-Controlled Multicentre Trial. Biomedicines, 2026. Link
  7. Xu X, et al. Comparing the Efficacy and Safety of Cell Transplantation for Spinal Cord Injury: A Systematic Review and Bayesian Network Meta-Analysis. Frontiers in Cellular Neuroscience, 2022. Link
  8. Ribeiro BF, et al. Cell therapies for spinal cord injury: a review of the clinical trials and cell-type therapeutic potential. Brain, 2023. Link
  9. Davoudi-Monfared E, et al. Adverse events of cell therapy clinical trials in human chronic spinal cord injury, a systematic review and meta-analysis. Regenerative Therapy, 2024. Link
  10. Zhao H, et al. Is cell transplantation a reliable therapeutic strategy for spinal cord injury in clinical practice? A systematic review and meta-analysis from 22 clinical controlled trials. European Spine Journal, 2019. Link
  11. Dobkin BH, et al. Cellular transplants in China: observational study from the largest human experiment in chronic spinal cord injury. Neurorehabilitation and Neural Repair, 2006. Link
  12. Spiess MR, et al. Conversion in ASIA impairment scale during the first year after traumatic spinal cord injury. Journal of Neurotrauma, 2009. Link
  13. 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
  14. U.S. Food and Drug Administration. Warning Letter: Dynamic Stem Cell Therapy, 712579, 02/11/2026. 2026. Link
  15. 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
  16. Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). La COFEPRIS suspendió clínica del D.F. que ofrecía tratamientos con Células Madre sin aval científico. Gobierno de México, COFEPRIS (press release), 2015. Link
  17. Kawaguchi H. Stem cell therapy for spinal cord injury: lessons from Japan's experiment in regulatory deregulation. The Spine Journal, 2026. Link
  18. Honmou O, et al. Intravenous infusion of auto serum-expanded autologous mesenchymal stem cells in spinal cord injury patients: 13 case series. Clinical Neurology and Neurosurgery, 2021. Link
  19. Noda S, et al. Regulatory advancements in Japan's conditional and time-limited approval scheme for regenerative medical products: the first guidance on the approval scheme and the second review for full approval of the first conditional and time-limited approved cellular product, HeartSheet. Cytotherapy, 2025. Link
  20. Akhlaghpasand M, et al. Safety and potential effects of intrathecal injection of allogeneic human umbilical cord mesenchymal stem cell-derived exosomes in complete subacute spinal cord injury: a first-in-human, single-arm, open-label, phase I clinical trial. Stem Cell Research & Therapy, 2024. Link
  21. U.S. Food and Drug Administration. Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. 2024. Link

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