Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-31 @ 10:51 AM
Study NCT ID:
NCT04368806
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2020-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis
Sponsor:
Nature Cell Co. Ltd.
Organization:
Study Overview
Official Title:
A 48-Weeks, Phase 2b/3a, Double-Blind, Randomized, Placebo Controlled, Multi-center, Superiority Study to Evaluate the Efficacy and Safety of JointStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells in Patients Diagnosed as Knee Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2025-07
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:
None
Brief Summary:
This study is a double-blind, randomized, placebo controlled, multi-center, superiority study to evaluate the efficacy and safety of JointStem, autologous adipose tissue derived mesenchymal stem cells (AdMSC), in patients diagnosed as knee osteoarthritis. Following a 2-week screening period, approximately 140 subjects will be randomly assigned into one of the following two arms in a 1:1 ratio (1 JointStem : 1 Placebo). After each subject completes 48-Weeks visit (Visit 8) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.
Detailed Description:
Study Procedures:
* Visit 1 (Week -7) - Screening
* Visit 2 (Week -5) - Baseline and Randomization (Lipoaspiration)
* Visit 3 (Week 0) - Treatment (Intra-articular injection)
* Visit 4 (Week 4) - 4 weeks follow-up
* Visit 5 (Week 12) - 12 weeks follow-up
* Visit 6 (Week 24) - 24 weeks follow-up
* Visit 7 (Week 36) - 36 weeks follow-up
* Visit 8 (Week 48) - 48 weeks follow-up (End of Study)
* Visit 1 (Week -7) - Screening
* Visit 2 (Week -5) - Baseline and Randomization (Lipoaspiration)
* Visit 3 (Week 0) - Treatment (Intra-articular injection)
* Visit 4 (Week 4) - 4 weeks follow-up
* Visit 5 (Week 12) - 12 weeks follow-up
* Visit 6 (Week 24) - 24 weeks follow-up
* Visit 7 (Week 36) - 36 weeks follow-up
* Visit 8 (Week 48) - 48 weeks follow-up (End of Study)
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: