NCT03403699: iPSC

Human iPSC for Repair of Vasodegenerative Vessels in Diabetic Retinopathy

Recruiting now Last updated 22 January 2026

What this trial tests

trial testing Generation of inducible pluripotent stem cells in Diabetes Complications in 20 participants. Currently enrolling.

Timeline

11 January 2018

Primary endpoint
31 December 2026

31 December 2027

Quick facts

Lead sponsor	University of Alabama at Birmingham
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	20
Start date	11 January 2018
Primary completion	31 December 2026
Estimated completion	31 December 2027
Sites	1 location across United States

Drugs / interventions tested

• Generation of inducible pluripotent stem cells — full drug profile →

Conditions studied

• Diabetes Complications — all drugs for Diabetes Complications →
• Diabetic Retinopathy — all drugs for Diabetic Retinopathy →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 21 to 98, any sex, with Diabetes Complications or Diabetic Retinopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Induced Pluripotent Stem Cells (iPSCs)-Roles in Regenerative Therapies, Disease Modelling and Drug Screening.
   Aboul-Soud MAM, Alzahrani AJ, Mahmoud A. · · 2021 · cited 137× · PMID 34571968 · DOI 10.3390/cells10092319
2. Neurovascular unit in diabetic retinopathy: pathophysiological roles and potential therapeutical targets.
   Nian S, Lo ACY, Mi Y, Ren K, et al · · 2021 · cited 95× · PMID 33931128 · DOI 10.1186/s40662-021-00239-1
3. Diabetic macular ischaemia- a new therapeutic target?
   Cheung CMG, Fawzi A, Teo KY, Fukuyama H, et al · · 2022 · cited 65× · PMID 34902545 · DOI 10.1016/j.preteyeres.2021.101033
4. Adult Stem Cell Therapeutics in Diabetic Retinopathy.
   Gaddam S, Periasamy R, Gangaraju R. · · 2019 · cited 38× · PMID 31575089 · DOI 10.3390/ijms20194876
5. Emerging roles of mesenchymal stem cell therapy in patients with critical limb ischemia.
   Shirbaghaee Z, Hassani M, Heidari Keshel S, Soleimani M. · · 2022 · cited 36× · PMID 36068595 · DOI 10.1186/s13287-022-03148-9
6. Insights into stem cell therapy for diabetic retinopathy: a bibliometric and visual analysis.
   Li XJ, Li CY, Bai D, Leng Y. · · 2021 · cited 32× · PMID 32788473 · DOI 10.4103/1673-5374.286974
7. Cell Replacement Therapy for Retinal and Optic Nerve Diseases: Cell Sources, Clinical Trials and Challenges.
   Coco-Martin RM, Pastor-Idoate S, Pastor JC. · · 2021 · cited 26× · PMID 34208272 · DOI 10.3390/pharmaceutics13060865
8. Diabetic Retinopathy: New Treatment Approaches Targeting Redox and Immune Mechanisms.
   Tang Q, Buonfiglio F, Böhm EW, Zhang L, et al · · 2024 · cited 25× · PMID 38790699 · DOI 10.3390/antiox13050594