Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2025-12-25 @ 1:06 PM
Study NCT ID:
NCT01736059
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-07
First Post:
2012-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy
Sponsor:
University of California, Davis
Organization:
Study Overview
Official Title:
A Pilot Clinical Trial of the Feasibility and Safety of Intravitreal Autologous Adult Bone Marrow Stem Cells in Treating Eyes With Vision Loss From Retinopathy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
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:
This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem cells from bone marrow into the eye as treatment for patients who are irreversibly blind from various retinal conditions.
Detailed Description:
In this pilot clinical trial, eyes with irreversible vision loss from retinal degenerative conditions (macular degeneration or retinitis pigmentosa) or retinal vascular disease (diabetic retinopathy or retinal vein occlusion) will be treated with intravitreal injection of autologous CD34+ stem cells isolated from bone marrow aspirate under Good Manufacturing Practice conditions. This study will determine whether there are any major safety and feasibility concerns using this therapy. Patients will be followed for 6 months after treatment by serial comprehensive eye examination supplemented with various retinal imaging and diagnostic tests.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BMSCRetPilot | OTHER | Other | View |