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Stem cell therapy for macular degeneration.

Clinics inject fat or bone marrow cells into or behind the eye. That has never been tested properly and has blinded patients. The regulated version, retinal cells implanted during surgery, is still in early trials.[1][2]

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Written by Eli McGarvie.

Clinics that treat macular degeneration.

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Eye surgery in a trial, or an injection at a clinic

Retinal cell implants, in trials

New retinal support cells, grown from stem cells, are placed under the retina during eye surgery. After about 15 years this is still at an early trial stage and is not approved anywhere.[3][2][4]

Fat or bone marrow injections, at clinics

Cells injected into the jelly of the eye or behind it. No regulated programme does this.[1][5]

What to expect

In a trial

A full eye operation under general anaesthetic, followed by days lying face down and up to two weeks of discomfort, as participants describe it.[6] Every regulated study treats one eye, once.[2][7]

Who it suits, and who it doesn't

Anyone who still has an approved treatment available should use it first. Being offered both eyes at once, or an injection into or behind the eye outside a trial, is a warning sign.[8][1][9]

Risks

Trial surgery has caused bleeding, retinal detachment and swelling.[10][2] Clinic injections of fat or marrow cells have caused high eye pressure, retinal detachment, a dislocated lens and blindness.[1][11]

Unproven in trials; clinic injections have caused blindness

Does it work? For clinic injections, no. For the trial implants, the cells survive, but no trial has compared the surgery with a sham operation, so any gain in vision is unproven.[12][2]

3 womenin Florida paid $5,000 each for injections into both eyes. A year later their vision ranged from 20/200 to no light at all.Case report, New England Journal of Medicine[1]
3.9 lettersgained in eyes given a mock injection, against 1.3 and 2.6 letters with cells, in a related retinal diseaseSham-controlled trial, 83 people[13]
15 patientsin the largest single implant study. No implant is approved anywhere.Phase 1 and 2 trials[2][4]
0 of 48online discussion threads contained a first-hand account of a clinic eye injectionOur review of patient accounts on Reddit and forums[6]

Where it is allowed

United States. The FDA names macular degeneration and blindness among conditions with no approved stem cell product.[14]

Malaysia. Cell products must be registered, and none is registered for any eye condition.[15] Advertising remedies for eye disease is banned.[16]

Mexico. COFEPRIS has said stem cell treatments lack authorisation.[17]

Specialists. The American Academy of Ophthalmology says these treatments belong in FDA-approved trials.[9]

Common questions

Will it restore my reading vision?

No published trial has restored reading vision.[2][18]

Does a ClinicalTrials.gov listing mean it is approved?

No. The Florida clinic had a listed study. One patient found the clinic through that listing and believed she was in a trial; the study now shows zero participants enrolled.[1][19]

Questions to ask a clinic

  1. Is this an FDA-approved trial, or an approved investigation? Can I see the approval?
  2. Am I being charged to take part? Genuine trials do not charge.
  3. Where do the cells go: under the retina in surgery, into the eye, or behind it?
  4. Will you treat one eye or both?
  5. Who is the retina surgeon, and can I see their registration?
  6. Will this rule me out of a regulated trial later?

Sources

19 references
  1. Kuriyan AE, et al. Vision Loss after Intravitreal Injection of Autologous "Stem Cells" for AMD. The New England Journal of Medicine, 2017. Link
  2. Humayun MS, et al. Long-term Follow-up of a Phase 1/2a Clinical Trial of a Stem Cell-Derived Bioengineered Retinal Pigment Epithelium Implant for Geographic Atrophy. Ophthalmology, 2024. Link
  3. Schwartz SD, et al. Human embryonic stem cell-derived retinal pigment epithelium in patients with age-related macular degeneration and Stargardt's macular dystrophy: follow-up of two open-label phase 1/2 studies. The Lancet, 2015. Link
  4. 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
  5. Kalavar M, et al. Update on "Cell Therapy" Clinics Offering Treatments of Ocular Conditions Using Direct-To-Consumer Marketing Websites in the U.S. American Journal of Ophthalmology, 2024. Link
  6. StemFinder review of first-hand patient accounts on Reddit and patient forums, 2026. Method
  7. Li SY, et al. A phase I clinical trial of human embryonic stem cell-derived retinal pigment epithelial cells for early-stage Stargardt macular degeneration: 5-years' follow-up. Cell Proliferation, 2021. Link
  8. Vemulakonda GA, et al. Age-Related Macular Degeneration Preferred Practice Pattern. American Academy of Ophthalmology, H. Dunbar Hoskins Jr., MD Center for Quality Eye Care, 2024. Link
  9. American Academy of Ophthalmology, Quality of Care Secretariat. Intraocular Stem Cell Therapy. American Academy of Ophthalmology, 2016. Link
  10. Kashani AH, et al. One-Year Follow-Up in a Phase 1/2a Clinical Trial of an Allogeneic RPE Cell Bioengineered Implant for Advanced Dry Age-Related Macular Degeneration. Translational Vision Science & Technology, 2021. Link
  11. Hussain RM, et al. Clinicopathologic Correlations of Retinal Membranes Associated With Intravitreal 'Stem Cell' Injections. Ophthalmic Surgery, Lasers & Imaging Retina, 2019. Link
  12. Kashani AH, et al. Survival of an HLA-mismatched, bioengineered RPE implant in dry age-related macular degeneration. Stem Cell Reports, 2022. Link
  13. jCyte, Inc. A Prospective, Multicenter, Randomized, Study of the Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa (RP). United States National Library of Medicine, ClinicalTrials.gov, 2026. Link
  14. U.S. Food and Drug Administration. Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. 2024. 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. Parliament of Malaysia. Medicines (Advertisement and Sale) Act 1956 (Act 290), Revised 1983, incorporating amendments to Act A778/1990. Pharmaceutical Services Programme, Ministry of Health Malaysia, 1990. Link
  17. Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS). La COFEPRIS suspendio clinica del D.F. que ofrecia tratamientos con Celulas Madre sin aval cientifico. Gobierno de Mexico, COFEPRIS (press release), 2015. Link
  18. Heier JS, et al. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials. The Lancet, 2023. Link
  19. Bioheart, Inc. An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Injected Intravitreal in Dry Macular Degeneration. United States National Library of Medicine, ClinicalTrials.gov, 2026. Link

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