Transplanting stem cells to treat dry age-related macular degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and tolerability of RPESC-RPE-4W, a therapy derived from allogeneic RPE stem cells, for patients suffering from dry age-related macular degeneration (AMD). The study is a Phase 1/2a open-label dose-escalation trial that aims to enroll 18 subjects who will receive subretinal injections of the stem cell-derived RPE cells. Participants will be monitored for any adverse effects and overall tolerability of the treatment. The goal is to assess whether this innovative approach can provide a new therapeutic option for individuals with this condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Clinical diagnosis of dry AMD.
2. Ability to understand and give informed consent.
3. Adult male or female \>55 years of age.
4. Medically suitable to undergo vitrectomy and subretinal injection (\>60% on Karnofsky scale).
5. Postmenopausal if female (expected to be common for the age limitation), or the female partner of a male subject unable to father children.
6. If male, willing to use barrier and spermicidal contraception during the study.

Exclusion Criteria:

1. Allergy or hypersensitivity to dilation drops or fluorescein.
2. Active major medical conditions limiting ability to participate in the study.
3. Active malignancy or treatment with chemotherapy.
4. Systemic immunosuppressant therapy within past six months.
5. History of toxoplasmosis, retinal histoplasmosis or tuberculosis.
6. Receipt of investigational product (IP) in a clinical trial within prior six months.
7. Any other medical condition, which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results.
8. Pregnant or nursing females.

Where it's running

• Retina Vitreous Associates Medical Group
  Beverly Hills, California, United States Recruiting
• Spencer Center for Vision Research
  Palo Alto, California, United States Recruiting
• University of Michigan Kellogg Eye Center
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Rajesh C Rao, M.D. — University of Michigan Kellogg Eye Center
• Study coordinator: Jeffrey H Stern, M.D., Ph.D.
• Email: jeffreystern@luxabiotech.com
• Phone: 05184371111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• OCU410 for Geographic Atrophy due to Dry AMD: treatment to help the eye

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• Subretinal CPCB-RPE1 implant for advanced dry AMD with geographic atrophy

  This trial will try a surgical CPCB-RPE1 implant in one eye to see if it is safe and helps people aged 55–90 with advanced dry AMD and geographic atrophy that involves the fovea.

  Recruiting at 5 sites Phase 2 Regenerative Patch Technologies, LLC · Huntington Beach, California and 4 other locations · NCT06557460

• Treatment for dry age-related macular degeneration using umbilical cord blood plasma

  This study is testing if injections of umbilical cord blood plasma can help older adults with dry age-related macular degeneration slow down or improve their vision.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome, Rome · NCT06536062

• Registry to assess light therapy for dry age-related macular degeneration

  This study is testing if a new light therapy can safely help people with dry age-related macular degeneration see better.

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• Treatment for dry age-related macular degeneration using umbilical cord blood platelet-rich plasma injections

  This study is testing if injections of umbilical cord blood platelets can help older adults with dry age-related macular degeneration keep their vision from getting worse.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome · NCT05706896

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.