Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)

Description

The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.

Conditions

Dry Age-related Macular Degeneration

Study Overview

Study Details

Study overview

The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.

A Phase1/2a, Open-Label Study to Evaluate the Safety and Tolerability of RPE Stem Cell-derived RPE (RPESC-RPE) Transplantation as Therapy for Dry Age-related Macular Degeneration (AMD)

Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)

Condition
Dry Age-related Macular Degeneration
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan Kellogg Eye Center, Ann Arbor, Michigan, United States, 48105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

55 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Luxa Biotechnology, LLC,

Rajesh C Rao, M.D., PRINCIPAL_INVESTIGATOR, University of Michigan Kellogg Eye Center

Study Record Dates

2025-05-31