Recruiting

iPSC

Sponsor:

University of Alabama at Birmingham

Code:

NCT03403699

Conditions

Diabetes Complications

Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Generation of inducible pluripotent stem cells

Study Details

Brief summary:

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.

Conditions

Diabetes Complications

Diabetic Retinopathy

Study ID

NCT03403699

Start date

Jan 11, 2018

Status verified date

Sep, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 either carry the diagnosis of diabetes or be a healthy aged control and b) the patient be willing and have the ability to cooperate with the eye exam and skin punch biopsy protocol.

Exclusion Criteria:

  • We will apply the following exclusion criteria: a) evidence of ongoing acute or chronic infection (HIV, Hepatitis B or C, tuberculosis); b) ongoing malignancy; c) cerebral vascular accident or cerebral vascular procedure; d) current pregnancy; e) history of organ transplantation; f) presence of a graft (to avoid any effect of the graft on inflammatory parameters; and g) patients with anemia. Subjects with AMD, glaucoma, uveitis, known hereditary degenerations or other significant ocular complications other than diabetic retinopathy will be excluded.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Generation of inducible pluripotent stem cells

Generation of inducible pluripotent stem cells from peripheral blood cells.

Primary outcome measure

  • Generating iPSCs from peripheral blood [ Time Frame: From blood draw to 4 months ]
  • Differentiate iPSCs into CD34+ cells and mesoderm [ Time Frame: 4 months to 4 years ]

Central Contacts and Locations

Central contacts

Jennifer Moorer

205 325 8674jmoorer@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Jennifer Moorer

2053258674jmoorer@uabmc.edu

Principal Investigator:

Maria B Grant, MD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jan 22, 2026

Last verified

Sep, 2025

Keywords

  • inducible pluripotent stem cells

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-01-22.