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What are the risks of stem cell therapy?

Published Sep 18, 2026Updated Sep 19, 2026Last verified Sep 18, 2026Requests recorded in this site’s own server logs, with the crawler identity checked by reverse DNS or IP range.Google10Yandex1First collected Sep 18, 2026Recent requestsGoogleSep 20, 2026GoogleSep 20, 2026GoogleSep 20, 2026GoogleSep 20, 2026GoogleSep 19, 2026GoogleSep 19, 2026GoogleSep 19, 2026GoogleSep 19, 2026GoogleSep 19, 2026GoogleSep 18, 2026YandexSep 18, 2026
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Quick answer

The risks depend on the treatment. After a donor-cell (allogeneic) transplant, graft-versus-host disease occurs in about 35–45% of patients with related donors and 60–80% with unrelated donors. Infections are another serious risk. With unapproved products, the FDA has reported blindness, tumor formation, sepsis, neurological events, unwanted immune reactions and cells moving to unintended sites.

54 words10 sources

Answer

In one published case series, three patients lost severe vision in both eyes after injections of their own fat-derived cells. At one year, their vision ranged from 20/200 to no light perception.[10]

Sources

  1. governmentImportant Patient and Consumer Information About Regenerative Medicine Therapies — U.S. Food and Drug Administration · accessed Sep 19, 2026 · Evidence page
  2. governmentApproved Cellular and Gene Therapy Products — U.S. Food and Drug Administration · accessed Sep 19, 2026 · Evidence page
  3. journalOne and a half million hematopoietic stem cell transplants: continuous and differential improvement in worldwide access with the use of non-identical family donors (Niederwieser D, et al., Haematologica 107(5):1045-1053) — Haematologica · accessed Sep 20, 2026 · Evidence page
  4. organizationStem Cell Resources for Patients — International Society for Stem Cell Research (ISSCR) · accessed Sep 20, 2026 · Evidence page
  5. governmentGraft-versus-host disease: MedlinePlus Medical Encyclopedia — U.S. National Library of Medicine (MedlinePlus) · accessed Sep 20, 2026 · Evidence page
  6. journalMesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World (Fernández-Garza LE, et al., Pharmaceuticals 16(9):1334) — Pharmaceuticals (MDPI) · accessed Sep 20, 2026 · Evidence page
  7. governmentAlofisel: EPAR — European Medicines Agency · accessed Sep 20, 2026 · Evidence page
  8. organizationFDA Approves Remestemcel-L-Rknd for Steroid-Refractory Acute Graft-Versus-Host Disease in Pediatric Patients — Oncology Nursing Society · accessed Sep 20, 2026 · Evidence page
  9. journalNew legal category of 'advanced regenerative medicine treatment' in Korea's amended regenerative medicine law: comparative lessons from Japan (Yoon, Lee, Kim) — Stem Cell Reports · accessed Sep 20, 2026 · Evidence page
  10. journalUnproven stem cell therapy for macular degeneration (Ansari ZA, Kuriyan AE, Albini TA) — Oncotarget · accessed Sep 20, 2026 · Evidence page