Ignite Creation Date:
2024-05-06 @ 8:16 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02709876
Status:
UNKNOWN
Last Update Posted:
2020-03-17
First Post:
2016-02-26
Brief Title:
Autologous Bone Marrow-Derived CD34 CD133 and CD271 Stem Cell Transplantation for Retinitis Pigmentosa
Sponsor:
Stem Cells Arabia
Organization:
Stem Cells Arabia
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A single arm single center trial to evaluate the safety and efficacy of autologous purified populations of bone-marrow derived stem cells in patients with Retinitis Pigmentosa BM-SCs through a 48 month follow up period
Detailed Description:
Retinitis pigmentosa RP is an inherited disorder of the photoreceptor cells in the retina Patients may lose vision since they were young or later in life Currently there are more than 60 genes identified as the cause of this condition one of which RPE65 has been studied in several gene therapy trials for Leber congenital amaurosis with promising results Another treatment approach for RP is stem cell therapy Studies in animal models of RP have shown that subretinal injection of bone marrow-derived mesenchymal stem cells may delay degenerative changes of photoreceptor cells This is a single arm single center trial to assess the safety and efficacy of purified adult autologous bone marrow derived CD34 CD133 and CD271 stem cells through a 48 month follow-up period The combination of these three cell types was based on their diverse potentialities to differentiate into specific functional cell types to regenerate damaged retinal tissue and the availability of clinical-grade purification system CliniMACS and microbeads to purify the target cell populations in clinically-approved methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None