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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 week 26 and week 52
Awards & highlights

Study 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 ~week 26 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of local and systemic treatment emergent adverse events (AEs) and incidence of abnormal laboratory and immunogenicity panels
Secondary outcome measures
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 patient global assessment of OA, by assessing the participants assessment of how they are doing considering arthritis in index knee (the possible answers include "Very Good", "Good", "Acceptable", "Poor", "Very Poor"
+3 more
Other outcome measures
Change from baseline in biochemical markers (CTX-II & PRO-C2)
Change from baseline in joint space width of the index knee, assessed radiographically (OARSI radiographic scoring)

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
15,228 Total Patients Enrolled
10 Trials studying Osteoarthritis
1,715 Patients Enrolled for Osteoarthritis
Annunziato Amendola, MDPrincipal InvestigatorJames R. Urbaniak, MD, Duke Sports Science Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
65+
What site did they apply to?
Coastal Carolina Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Osteoarthritis and CartilageJournal
A Novel Placental Tissue Biologic, PTP-001, Inhibits Inflammatory and Catabolic Responses in Vitro and Prevents Pain and Cartilage Degeneration in a Rat Model of Osteoarthritis
Flannery, C.R., S.A. Seaman, K.E. Buddin, M.A. Nasert, E.J. Semler, K.L. Kelley, M. Long, J. Favret, A. Pavesio, and R.F. Loeser. 2021. “A Novel Placental Tissue Biologic, PTP-001, Inhibits Inflammatory and Catabolic Responses in Vitro and Prevents Pain and Cartilage Degeneration in a Rat Model of Osteoarthritis”. Osteoarthritis and Cartilage. Elsevier BV. doi:10.1016/j.joca.2021.03.022.
clinicaltrials.govStudy
Safety Study of PTP-001 for Treating Knee Osteoarthritis
2021. "Safety Study of PTP-001 for Treating Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04632966.
All > Knee Osteoarthritis
~5 spots leftby Apr 2025
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