Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-28 @ 6:45 PM
Study NCT ID:
NCT01809769
Status:
COMPLETED
Last Update Posted:
2016-04-04
First Post:
2013-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis
Sponsor:
Shanghai AbelZeta Ltd.
Organization:
Study Overview
Official Title:
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis by Intra-articular Injection: A PhaseⅠ/Ⅱa, Randomized and Double-blinded Clinical Trial
Status:
COMPLETED
Status Verified Date:
2016-04
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:
Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following initial injection.
Detailed Description:
Adipose (fat) tissue is removed by lipo-aspiration (this may take up to 40 minutes). The fat is processed on-site to isolate and obtain the MSCs,then proliferate them. The suspension of the cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).
Study Oversight
Has Oversight DMC:
True
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?: