Ignite Creation Date:
2024-05-06 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05148598
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-09-28
First Post:
2021-11-20
Brief Title:
ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma
Sponsor:
Paracrine INC
Organization:
Paracrine INC
Study Overview
Official Title:
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells - A Randomized Double-Blind Placebo-Controlled Study - The STAR-II Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-12
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:
STAR-II
Brief Summary:
The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells ADRCs in the treatment of hand dysfunction due to scleroderma
Detailed Description:
The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells ADRCs in the treatment of hand dysfunction due to scleroderma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None