Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536062
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Age-related Macular Degeneration of Atrophic Type Treated With Intravitreal Injection of Umbilical Cord Blood Enriched With Platelet Plasma Multicenter Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
M-CORD IV
Brief Summary:
The objective of the study will be to evaluate the efficacy of intravitreal injections of Umbilical Cord Blood Platelet-rich Plasma CB-PRP in order to reduce or stabilize the atrophic progression in dry Age-related Macular Degeneration AMD
Detailed Description:
Patients will undergo intravitreal injections of CB-PRP Cord Blood Platelet-rich Plasma according to three different treatment regimens and the efficacy and safety of CB-PRP in an in vitro model of lipopolysaccharide LPS-induced degeneration in hTERT RPE-1 and ARPE-19 model cell lines derived from retinal pigmented epithelium RPE will be evaluated
The purpose of this study is to evaluate the safety and efficacy of different temporal regimens of intravitreal administration of CB-PRP and the response of photoreceptors in the macular region in dry-AMD Microanatomical changes in the retina induced by intravitreal CB-PRP therapy and measured by advanced retinal imaging techniques will be evaluated as an important signal of efficacy
The purpose of this study is to evaluate the safety and efficacy of different temporal regimens of intravitreal administration of CB-PRP and the response of photoreceptors in the macular region in dry-AMD Microanatomical changes in the retina induced by intravitreal CB-PRP therapy and measured by advanced retinal imaging techniques will be evaluated as an important signal of efficacy
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