Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05909488
Status:
RECRUITING
Last Update Posted:
2023-08-04
First Post:
2023-03-14
Brief Title:
Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase III
Sponsor:
PT Prodia Stem Cell Indonesia
Organization:
PT Prodia Stem Cell Indonesia
Study Overview
Official Title:
Role of Umbilical Cord-derived Stem Cell Transplantation and Conditioned Medium to Inhibit Vision Loss in Retinitis Pigmentosa Phase III
Status:
RECRUITING
Status Verified Date:
2023-08
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:
The study will perform UC-MSCs and CM transplantation There are two groups with different dosages The first group will be transplanted with 15 million cells meanwhile the second group is 5 million cells Each group consists of 30 subjects All groups will be transplanted via the peribulbar route All groups will be observed until six months
Detailed Description:
The eyes we will give the transplant should be given an aseptic and antiseptic technique to prevent contamination from the inside and outside Sterile cover attached to other parts of the face except for the eyes 18 ml Umbilical Cord-derived Mesenchymal Stem Cell UC-MSC preparations are suspended in Conditioned Medium CM until it reaches a 2 ml volume of cell suspension Two dosages will be prepared 15 million and 5 million of UC-MSC Stem cell suspension will be injected by peribulbar and patients will be given a quinolone antibiotic if the injection is done On day 1st and day 7th after therapy patients will be observed the presence of infection inflammation and increased eye pressure On day 7th day 30th and day 90th after therapy patients will do a visual field test visual acuity test electroretinography funduscopy and Optical Coherence Tomography examination The observations will be written in the table and analyzed by a statistic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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