Safety Study of PTP-001 for Treating Knee Osteoarthritis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Knee Osteoarthritis
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Open-label, dose-escalationMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 80 years
- Gender
- Both males and females
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) i...
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).
Tracking Information
- NCT #
- NCT04632966
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Annunziato Amendola, MD James R. Urbaniak, MD, Duke Sports Science Institute
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