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| Sponsor: | Advanced Cell Technology |
|---|---|
| Information provided by (Responsible Party): | Advanced Cell Technology |
| ClinicalTrials.gov Identifier: | NCT01344993 |
Purpose
This is a safety and tolerability trial to evaluate the effect of subretinal injection of human embryonic stem cell derived retinal pigment epithelium cells in patients with dry Age Related Macular Degeneration (AMD) and to perform exploratory evaluation of potential efficacy endpoints to be used in future studies retinal pigment epithelium (RPE) cellular therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Dry Age Related Macular Degeneration |
Biological: MA09-hRPE Cellular Therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | A Phase I/II, Open-Label, Multi-Center, Prospective Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (MA09-hRPE) Cells in Patients With Advanced Dry AMD |
The transplantation of hESC-derived RPE cells MA09-hRPE will be considered safe and tolerated in the absence of:
Secondary endpoints will be evaluated as exploratory evaluations for potential efficacy endpoints.
Evidence of successful engraftment will consist of:
| Estimated Enrollment: | 12 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
This study will be a phase I/II, open-label, non randomized, sequential, multi-center safety and tolerability trial to evaluate the effect of subretinal injection of human embryonic stem cell derived retinal pigment epithelium cells in patients with dry AMD and to perform exploratory evaluation of potential efficacy endpoints to be used in future studies RPE cellular therapy. Patients will be enrolled sequentially, and the clinical course of each patient treated will be reviewed by an independent Data Safety Monitoring Board (DSMB) before the next patient is enrolled.
Each eligible patient who signs a consent form and fulfills all (Inclusion/Exclusion) criteria will receive a single uniocular subretinal infusion of MA09-hRPE cells in one of four dose levels.
Six weeks after the first patient in each dose cohort receives the cell transplant, the DSMB will review the clinical data and recommend if the next two patients in the dose cohort may be treated. Each cohort of 3 patients will be reviewed by the DSMB when the 3rd patient completes 4 weeks of follow-up.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Any laboratory value which falls slightly outside of the normal range will be reviewed by the Medical Monitor and Investigators to determine its clinical significance. If it is determined not to be clinically significant, the patient may be enrolled into the study.
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Jules Stein Eye Institute, UCLA School of Medicine | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Logan Hitchcock 310-825-3046 | |
| Principal Investigator: Steven Schwartz, MD | |
| United States, Florida | |
| Bascom Palmer Eye Institute | Recruiting |
| Miami, Florida, United States | |
| Contact: Cristy M Lage-Rodriguez, M.S., C.C.R.C 305-326-6117 CLage@med.miami.edu | |
| Principal Investigator: Philip Rosenfeld, MD, PhD | |
| United States, Massachusetts | |
| Mass Eye and Ear | Recruiting |
| Boston, Massachusetts, United States | |
| Contact: Carolyn Kwiat 617-573-3634 carolyn_kwait@meei.harvard.edu | |
| Principal Investigator: Dean Eliott, MD | |
| United States, Pennsylvania | |
| Wills Eye Institute-Mid Atlantic Retina | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Shellie Markun research@midatlanticretina.com | |
| Principal Investigator: Carl D Regillo, MD | |
| Principal Investigator: | Steven Schwartz, MD | Jules Stein Eye Institute-UCLA |
| Principal Investigator: | Carl D Regillo, MD | Wills Eye Institute-Mid Atlantic Retina |
| Principal Investigator: | Philip Rosenfeld, MD, PhD | Bascom Palmer Eye Institute |
| Principal Investigator: | Dean Eliott, MD | Massachusetts Eye and Ear |
More Information
| Responsible Party: | Advanced Cell Technology |
| ClinicalTrials.gov Identifier: | NCT01344993 History of Changes |
| Other Study ID Numbers: | ACT MA09-hRPE AMD-001 |
| Study First Received: | April 28, 2011 |
| Last Updated: | May 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Dry AMD Geographic atrophy |
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |