Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-28 @ 12:44 PM
Study NCT ID:
NCT04632966
Status:
UNKNOWN
Last Update Posted:
2021-12-22
First Post:
2020-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of PTP-001 for Treating Knee Osteoarthritis
Sponsor:
Bioventus LLC
Organization:
Study Overview
Official Title:
A Prospective, Open-Label, Dose-Escalation Phase 1 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Evaluation of safety, tolerability, and efficacy of a single intra-articular (IA) injection of PTP-001, an allogeneic placental tissue particulate, in individuals with knee osteoarthritis (OA).
Detailed Description:
This open-label, dose-escalation study is expected to enroll 20 participants, 40-80 years of age and test two doses (low and high dose) of PTP-001, an allogeneic placental tissue particulate, in two unique cohorts of 10 participants each. Each participant will receive a single intra-articular (IA) injection of PTP-001. Following the completion of the first cohort in which 10 participants (Kellgren-Lawrence Grade 2 or 3 knee OA) will be treated with the low dose of PTP-001, safety data will be reviewed by an independent Data and Safety Monitoring Board (DSMB).
Study Oversight
Has Oversight DMC:
True
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?: