Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04835389
Status:
WITHDRAWN
Last Update Posted:
2021-07-08
First Post:
2020-12-11
Brief Title:
Study of AlloGen Liquid Intra-articular Injection for Knee Osteoarthritis
Sponsor:
VIVEX Biologics Inc
Organization:
VIVEX Biologics Inc
Study Overview
Official Title:
A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of AlloGen Liquid Intra-articular Injection for Knee Osteoarthritis
Status:
WITHDRAWN
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company decision
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized double-blind placebo-controlled trial comparing a single intra-articular injection of 20 mL AlloGen vs 20 mL sterile saline Patients will be evaluated at baseline 1 week 6 weeks 12 weeks and 26 weeks
Detailed Description:
This is a Phase 1 randomized double-blind placebo-controlled trial comparing a single intra-articular 20 mL injection of either AlloGen or sterile saline Patients will be evaluated at baseline 1 week 6 weeks 12 weeks and 26 weeks The patient will remain blinded to his or her treatment throughout the study duration The investigatorassessor will also remain blinded throughout the treatment period Only the individuals preparing the injection will not be blinded Black tape over the injection syringe will mask the study treatment
Up to 30 adult patients with osteoarthritis of one knee that has failed to adequately respond to conservative non-pharmacologic therapy and simple analgesics eg acetaminophen will be enrolled at up to 5 sites in the US The first 6 subjects will be staggered to evaluate any significant toxicity Any adverse event data collected will be reviewed by the Data Safety Monitoring Board DSMB prior to treating the subsequent subject Cumulative safety data from these 6 subjects will be reviewed by the DSMB
Up to 30 adult patients with osteoarthritis of one knee that has failed to adequately respond to conservative non-pharmacologic therapy and simple analgesics eg acetaminophen will be enrolled at up to 5 sites in the US The first 6 subjects will be staggered to evaluate any significant toxicity Any adverse event data collected will be reviewed by the Data Safety Monitoring Board DSMB prior to treating the subsequent subject Cumulative safety data from these 6 subjects will be reviewed by the DSMB
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None