drugset / Trial / NCT02846571
Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye
Phase 1/2
Recruiting
2 enrolled
Midhat H. Abdulreda
Bascom Palmer Eye Institute · collabDiabetes Research Institute Foundation · collab
NaSingle-groupOpen-labelTreatment
Summary
The intervention in this trial is intraocular islet transplantation. A single dose of 1000 - 3000 Islet Equivalents (IEQ)/kg recipient body weight (BW) will be infused into the anterior chamber of the eye through a self-sealing incision in the peripheral cornea. The procedure is projected to take approximately 20-30 minutes. Transplant recipients in this study will receive localized maintenance immunosuppression via topical application of eye-drops.
Timeline
- Start
- 2019-12-05
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
Publications
- Background Perez VL, Caicedo A, Berman DM, Arrieta E, Abdulreda MH, Rodriguez-Diaz R, Pileggi A, Hernandez E, Dubovy SR, Parel JM, Ricordi C, Kenyon NM, Kenyon NS, Berggren PO. The anterior chamber of the eye as a clinical transplantation site for the treatment of diabetes: a study in a baboon model of diabetes. Diabetologia. 2011 May;54(5):1121-6. doi: 10.1007/s00125-011-2091-y. Epub 2011 Mar 1.
- Background Shishido A, Caicedo A, Rodriguez-Diaz R, Pileggi A, Berggren PO, Abdulreda MH. Clinical intraocular islet transplantation is not a number issue. CellR4 Repair Replace Regen Reprogram. 2016;4(4):e2120. Epub 2016 Jul 26.
- Background Tun SBB, Chua M, Hasan R, Kohler M, Zheng X, Ali Y, Abdulreda MH, Juntti-Berggren L, Barathi VA, Berggren PO. Islet Transplantation to the Anterior Chamber of the Eye-A Future Treatment Option for Insulin-Deficient Type-2 Diabetics? A Case Report from a Nonhuman Type-2 Diabetic Primate. Cell Transplant. 2020 Jan-Dec;29:963689720913256. doi: 10.1177/0963689720913256.
- Background Abdulreda MH, Berman DM, Shishido A, Martin C, Hossameldin M, Tschiggfrie A, Hernandez LF, Hernandez A, Ricordi C, Parel JM, Jankowska-Gan E, Burlingham WJ, Arrieta-Quintero EA, Perez VL, Kenyon NS, Berggren PO. Operational immune tolerance towards transplanted allogeneic pancreatic islets in mice and a non-human primate. Diabetologia. 2019 May;62(5):811-821. doi: 10.1007/s00125-019-4814-4. Epub 2019 Jan 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Human Pancreatic Islet Transplantation | Cell therapy | 1000 unknown | Other |
| Subject | Human Pancreatic Islet Transplantation | Cell therapy | 3000 unknown | Other |