NCT03403699

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
20mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Jan 2018Dec 2027

First Submitted

Initial submission to the registry

January 11, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 22, 2026

Status Verified

September 1, 2025

Enrollment Period

9 years

First QC Date

January 11, 2018

Last Update Submit

January 20, 2026

Conditions

Diabetes ComplicationsDiabetic Retinopathy

Keywords

inducible pluripotent stem cells

Outcome Measures

Primary Outcomes (2)

  • Generating iPSCs from peripheral blood

    Blood will be collected from the patient and cells will be isolated and shipped to ALSTEM for generation of iPSCs

    From blood draw to 4 months

  • Differentiate iPSCs into CD34+ cells and mesoderm

    Specific cell culture conditions will be used to differentiate the cells into these two distinct populations

    4 months to 4 years

Study Arms (2)

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.

Biological: Generation of inducible pluripotent stem cells

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.

Biological: Generation of inducible pluripotent stem cells

Interventions

Generation of inducible pluripotent stem cellsBIOLOGICAL

Generation of inducible pluripotent stem cells from peripheral blood cells.

Diabeticnondiabetics

Eligibility Criteria

Age21 Years - 98 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have retinal abnormalities other than diabetic retinopathy will be excluded. Patients who have history of malignant disease or hematologic disorder. We will record medications that the patient is taking at the time of biopsy. Baseline characteristics will also be recorded, including age, lipid parameters, body mass index, blood pressure, smoking history, antioxidant intake and use of nutritional supplements.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Inducible pluripotent stem cells will be generated and cryopreserved.

MeSH Terms

Conditions

Diabetes ComplicationsDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Diabetes MellitusEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular Diseases

Study Officials

  • Maria B Grant, MD

    1954

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Moorer

CONTACT

205 325 8674jmoorer@uabmc.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 19, 2018

Study Start

January 11, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

January 22, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)