RECRUITING

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

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Conditions

Dry Age-related Macular Degeneration

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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)

Quick Facts

Study Start:2022-04-05
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04627428

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.

Ages Eligible for Study:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Clinical diagnosis of dry AMD.
  2. 2. Ability to understand and give informed consent.
  3. 3. Adult male or female \>55 years of age.
  4. 4. Medically suitable to undergo vitrectomy and subretinal injection (\>60% on Karnofsky scale).
  5. 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. 6. If male, willing to use barrier and spermicidal contraception during the study.
  1. 1. Allergy or hypersensitivity to dilation drops or fluorescein.
  2. 2. Active major medical conditions limiting ability to participate in the study.
  3. 3. Active malignancy or treatment with chemotherapy.
  4. 4. Systemic immunosuppressant therapy within past six months.
  5. 5. History of toxoplasmosis, retinal histoplasmosis or tuberculosis.
  6. 6. Receipt of investigational product (IP) in a clinical trial within prior six months.
  7. 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. 8. Pregnant or nursing females.

Contacts and Locations

Study Contact

Jeffrey H Stern, M.D., Ph.D.
CONTACT
05184371111
jeffreystern@luxabiotech.com

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Luxa Biotechnology, LLC

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-05
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2022-04-05
Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Dry Age-related Macular Degeneration