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NCT02445612
Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Stargardt Macular Dystrophy Patients
trial testing MA09-hRPE in Stargardt's Macular Dystrophy in 13 participants. Completed in 21 June 2019.
21 June 2019
Quick facts
| Lead sponsor | Astellas Institute for Regenerative Medicine |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 13 |
| Start date | 11 July 2012 |
| Primary completion | 21 June 2019 |
| Estimated completion | 21 June 2019 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- MA09-hRPE — full drug profile →
Conditions studied
- Stargardt's Macular Dystrophy — all drugs for Stargardt's Macular Dystrophy →
Sponsor
Astellas Institute for Regenerative Medicine — full company profile →
Who can join
18 and older, any sex, with Stargardt's Macular Dystrophy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the long term safety and tolerability of MA09-hRPE cellular therapy in patients with advanced Stargardt's Macular Dystrophy (SMD) from one to five years following the surgical procedure to implant the MA09-hRPE cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Identification and Rescue of Splice Defects Caused by Two Neighboring Deep-Intronic ABCA4 Mutations Underlying Stargardt Disease.
Albert S, Garanto A, Sangermano R, Khan M, et al · · 2018 · cited 113× · PMID 29526278 · DOI 10.1016/j.ajhg.2018.02.008 -
Comparing the Therapeutic Potential of Stem Cells and their Secretory Products in Regenerative Medicine.
Foo JB, Looi QH, Chong PP, Hassan NH, et al · · 2021 · cited 89× · PMID 34422061 · DOI 10.1155/2021/2616807 -
Let There Be Light: Gene and Cell Therapy for Blindness.
Dalkara D, Goureau O, Marazova K, Sahel JA. · · 2016 · cited 89× · PMID 26751519 · DOI 10.1089/hum.2015.147 -
Therapeutic Application of Pluripotent Stem Cells: Challenges and Risks.
Martin U. · · 2017 · cited 50× · PMID 29312943 · DOI 10.3389/fmed.2017.00229 -
Recent Trends in Research with Human Pluripotent Stem Cells: Impact of Research and Use of Cell Lines in Experimental Research and Clinical Trials.
Guhr A, Kobold S, Seltmann S, Seiler Wulczyn AEM, et al · · 2018 · cited 45× · PMID 30033087 · DOI 10.1016/j.stemcr.2018.06.012 -
Two decades of embryonic stem cells: a historical overview.
Eguizabal C, Aran B, Chuva de Sousa Lopes SM, Geens M, et al · · 2019 · cited 38× · PMID 30895264 · DOI 10.1093/hropen/hoy024 -
Therapy Approaches for Stargardt Disease.
Piotter E, McClements ME, MacLaren RE. · · 2021 · cited 33× · PMID 34439845 · DOI 10.3390/biom11081179 -
Trends of Stem Cell Therapies in Age-Related Macular Degeneration.
Maeda T, Sugita S, Kurimoto Y, Takahashi M. · · 2021 · cited 33× · PMID 33923985 · DOI 10.3390/jcm10081785
Verify or expand the search:
- PubMed search for NCT02445612
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MA09-hRPE
Trials testing the same drug.
- NCT02463344 — Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Patients With AMD · completed
- NCT01469832 — Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial · Phase 1, PHASE2 · completed
- NCT01345006 — Sub-retinal Transplantation of hESC Derived RPE(MA09-hRPE)Cells in Patients With Stargardt's Macular Dystrophy · Phase 1, PHASE2 · completed
- NCT01344993 — Safety and Tolerability of Sub-retinal Transplantation of hESC Derived RPE (MA09-hRPE) Cells in Patients With Advanced D · Phase 1, PHASE2 · completed
Other Astellas Institute for Regenerative Medicine trials
Trials by the same sponsor.
- NCT03178149 — A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due · Phase 1 · recruiting
- NCT03167203 — A Safety Surveillance Study in Subjects With Macular Degenerative Disease Treated With Human Embryonic Stem Cell-derived · Phase 1, PHASE2 · enrolling by invitation
- NCT02563782 — Study to Evaluate Sub-retinal Transplantation of Retinal Pigmented Epithelial Cells in Patients With Dry AMD · Phase 2 · withdrawn
- NCT02463344 — Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Patients With AMD · completed
- NCT02941991 — A Follow up Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell D · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02445612 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Astellas Institute for Regenerative Medicine
- Last refreshed: 31 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02445612.
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