NCT03403699 Human iPSC for Repair of Vasodegenerative Vessels in Diabetic Retinopathy
| NCT ID | NCT03403699 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Diabetes Complications |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2018-01-11 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2018-01-11 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Maria B Grant, MD
PRINCIPAL INVESTIGATOR
1954
Frequently Asked Questions
Who can join the NCT03403699 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 98 Years, studying Diabetes Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03403699 currently recruiting?
Yes, NCT03403699 is actively recruiting participants. Contact the research team at jmoorer@uabmc.edu for enrollment information.
Where is the NCT03403699 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT03403699 clinical trial?
NCT03403699 is sponsored by University of Alabama at Birmingham. The principal investigator is Maria B Grant, MD at 1954. The trial plans to enroll 20 participants.
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