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Allogeneic Tissue Therapy

Biological: PTP-001 for Osteoarthritis

Phase 1
Waitlist Available
Led By Annunziato Amendola, MD
Research Sponsored by Bioventus LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 52
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at whether an injection of PTP-001, made from placental tissue, is safe and effective in treating knee osteoarthritis.

Eligible Conditions
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of local and systemic treatment emergent adverse events (AEs) and incidence of abnormal laboratory and immunogenicity panels
Secondary study objectives
Change from baseline in health-related quality of life, by assessing the items from the Short Form 36 (SF-36) survey
Change from baseline in pain of the index knee, by evaluating the WOMAC Pain subscale score (the possible total score ranging from 0-50 for pain)
Change from baseline in physical function of the index knee, by evaluating the WOMAC Physical Function subscale score (the possible total score ranging from 0-170 for Physical Function)
Other study objectives
Change from baseline in biochemical markers (CTX-II & PRO-C2)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: PTP-001 - Low Dose (100 mg)Experimental Treatment1 Intervention
intra-articular injection of 100 mg PTP-001 resuspended with 4 mL of normal saline
Group II: PTP-001 - High Dose (200 mg)Experimental Treatment1 Intervention
intra-articular injection of 200 mg PTP-001 resuspended with 4 mL of normal saline

Find a Location

Who is running the clinical trial?

Bioventus LLCLead Sponsor
16 Previous Clinical Trials
15,211 Total Patients Enrolled
10 Trials studying Osteoarthritis
1,698 Patients Enrolled for Osteoarthritis
Annunziato Amendola, MDPrincipal InvestigatorJames R. Urbaniak, MD, Duke Sports Science Institute
~4 spots leftby Nov 2025
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