Human iPSC for Repair of Vasodegenerative Vessels in Diabetic Retinopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-98
SponsorUniversity of Alabama at Birmingham
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Generation of inducible pluripotent stem cells
Biological/VaccineGeneration of inducible pluripotent stem cells from peripheral blood cells.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: nondiabetics1 intervention
Group B: Diabetic1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From blood draw to 4 months2
Differentiate iPSCs into CD34+ cells and mesoderm
Specific cell culture conditions will be used to differentiate the cells into these two distinct populations
Time frame
4 months to 4 yearsSponsors and contacts
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Source ClinicalTrials.gov