Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03981549
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2019-06-06
Brief Title:
Treatment of Central Retinal Vein Occlusion Using Stem Cells Study
Sponsor:
The Emmes Company LLC
Organization:
The Emmes Company LLC
Study Overview
Official Title:
Phase III Randomized Prospective Double-masked Sham-controlled Study of Intravitreal Autologous Bone Marrow CD34 Stem Cell Therapy for Central Retinal Vein Occlusion
Status:
COMPLETED
Status Verified Date:
2024-07
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:
TRUST
Brief Summary:
This study evaluates whether intravitreal autologous CD34 stem cell therapy is safe feasible and potentially beneficial in eyes with vision loss from central retinal vein occlusion CRVO Half of the participants will receive immediate cellular therapy followed by sham therapy 6 months later while the other half will receive immediate sham therapy followed by cellular therapy 6 months later Participants will be followed for a total of 1 year
Detailed Description:
The goal of this phase III prospective randomized sham-controlled double-masked clinical trial is to determine whether intravitreal autologous CD34 stem cell therapy is safe feasible and potentially beneficial in eyes with vision loss from central retinal vein occlusion CRVO Retinal Vein Occlusion RVO is a leading retinal vascular cause of vision loss in the elderly CD34 stem cells in human bone marrow are mobilized into the circulation in response to tissue ischemia for tissue revascularization and repair Since local delivery of CD34 stem cells benefits ischemic tissue intravitreal delivery of CD34 stem cells may benefit vision and retinal ischemia in eyes with RVO A pilot clinical trial has shown no major safety or feasibility concerns using intravitreal autologous CD34 bone marrow stem cells In this proposed expanded phase III study 20 participants 20 eyes with persistent vision loss from CRVO will be enrolled and followed for 1 year
Participants will be randomized 11 to immediate cell therapydeferred sham therapy or immediate sham therapydeferred cell therapy At month 6 the cell treated eye will receive sham treatment and the sham treated eye will get cell therapy The cellular therapy involves bone marrow aspiration isolation of CD34 cells from the aspirate under Good Manufacturing Practice GMP conditions and intravitreal injection of isolated CD34 cells The sham therapy involves a sham bone marrow aspiration with penetration of the skin but no penetration of the bone and a sham intravitreal injection without penetrating the eye The participant examining ophthalmologist visual acuity examiner photographers and OCT perimetry and electroretinography ERG technicians will remain masked to study treatment assignment for study duration A comprehensive eye examination with ETDRS best-corrected visual acuity optical coherence tomography OCT and OCT angiography OCTA autofluorescence fundus photography fluorescein angiography microperimetry and electroretinography will be performed at baseline and serially A subset of participants with good fixation on microperimetry and clear media on exam and commercial-grade OCTA and who give consent will have ultra-high resolution cellular retinal imaging using research-grade OCT and OCTA and adaptive optics-OCT at baseline Participants with high quality images will have repeat imaging at 1 month after stem cell treatment with at least 2 of the participants randomized to the deferred cellular therapy arm also having imaging 1 month after sham therapy For all participants in whom at least 15 million CD34 cells are harvested about 200000 cells will be set aside for post-release flow cytometry characterization to determine the composition of the CD34 enriched final product in terms of hematopoietic versus angiogenic stem cells based on cell surface markers ie CD133CD45CD34 vs CD31VEGFR-2CD45-CD34 The long-term objective is to determine whether intravitreal autologous CD34 cell therapy can minimize or reverse vision loss associated with retinal ischemia without compromising safety
Participants will be randomized 11 to immediate cell therapydeferred sham therapy or immediate sham therapydeferred cell therapy At month 6 the cell treated eye will receive sham treatment and the sham treated eye will get cell therapy The cellular therapy involves bone marrow aspiration isolation of CD34 cells from the aspirate under Good Manufacturing Practice GMP conditions and intravitreal injection of isolated CD34 cells The sham therapy involves a sham bone marrow aspiration with penetration of the skin but no penetration of the bone and a sham intravitreal injection without penetrating the eye The participant examining ophthalmologist visual acuity examiner photographers and OCT perimetry and electroretinography ERG technicians will remain masked to study treatment assignment for study duration A comprehensive eye examination with ETDRS best-corrected visual acuity optical coherence tomography OCT and OCT angiography OCTA autofluorescence fundus photography fluorescein angiography microperimetry and electroretinography will be performed at baseline and serially A subset of participants with good fixation on microperimetry and clear media on exam and commercial-grade OCTA and who give consent will have ultra-high resolution cellular retinal imaging using research-grade OCT and OCTA and adaptive optics-OCT at baseline Participants with high quality images will have repeat imaging at 1 month after stem cell treatment with at least 2 of the participants randomized to the deferred cellular therapy arm also having imaging 1 month after sham therapy For all participants in whom at least 15 million CD34 cells are harvested about 200000 cells will be set aside for post-release flow cytometry characterization to determine the composition of the CD34 enriched final product in terms of hematopoietic versus angiogenic stem cells based on cell surface markers ie CD133CD45CD34 vs CD31VEGFR-2CD45-CD34 The long-term objective is to determine whether intravitreal autologous CD34 cell therapy can minimize or reverse vision loss associated with retinal ischemia without compromising safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1UG1EY028517-01 | NIH | None | httpsreporternihgovquickSearch1UG1EY028517-01 |
| 1UG1EY026876-01A1 | NIH | None | None |