Human iPSC for Repair of Vasodegenerative Vessels in Diabetic Retinopathy

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT03403699
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 98 Years
Healthy Volunteers
Accepted

Interventions

  • Generation of inducible pluripotent stem cells — BIOLOGICAL
    Generation of inducible pluripotent stem cells from peripheral blood cells.

Study Details

This study proposes to carefully examine the hypothesis that human inducible pluripotent stem cells (iPSCs) can be effectively employed as a future therapeutic option for individuals with diabetic retinopathy and macular ischemia. iPSCs will be generated from the peripheral blood cells of subjects with diabetes and age matched controls. The human iPSC cells will be used to generate mesoderm cells for injection into the vitreous cavity of diabetic rodents and primate eyes. The ability of mesoderm cells to generate endothelial cells and pericytes in areas of degenerated capillaries will be examined. The human iPSCs will also be used to generate hematopoietic CD34+CD45+ cells. The combination of CD34+CD45+ cells derived from iPSCs and iPSC derived mesoderm will be examined in combination for their potentially beneficial effect to enhance the vessel formation.

Key Dates

Start date
Jan 11, 2018
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: nondiabetics
    Any man or woman between the ages of 21- 98 years of age will be eligible to participate. To participate in the study as a study subject we will require: a) the subject must be a healthy control and b) the subject be willing and have the ability to cooperate with the eye exam and blood draw.
  • Arm: Diabetic
    Any man or woman between the ages of 21- 98 years of age will be eligible to participate. To participate in the study as a study subject we will require: a) carry the diagnosis of diabetes and b) the subject be willing and have the ability to cooperate with the eye exam and blood draw.

Primary Outcome Measure

Generating iPSCs from peripheral blood [ Time Frame: From blood draw to 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Jennifer Moorer
2053258674
Maria B Grant, MD (PRINCIPAL_INVESTIGATOR)

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