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Allogeneic Cell Therapy

PTP-001 for Osteoarthritis

Phase 2
Waitlist Available
Led By Moin Khan, 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 at 2 weeks, 3 months, 4 months, 5 months, and 6 months.
Awards & highlights

Study Summary

This trial is testing an injection for knee pain that comes from placenta tissue. They want to know if it is safe and works.

Eligible Conditions
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 weeks, 3 months, 4 months, 5 months, and 6 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 weeks, 3 months, 4 months, 5 months, and 6 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy - Change from pretreatment baseline in the WOMAC pain subscale
Safety - Incidence of local and systemic AEs
Secondary outcome measures
Change from pretreatment baseline in function assessed by participant self-report (WOMAC Function subscale).
Change from pretreatment baseline in pain intensity assessed by participant self report (WOMAC Pain subscale).
Change from pretreatment baseline in participant self-reported quality of life measured by SF-36 overall score, PCS, and MCS.
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: PTP-001 200 mgExperimental Treatment1 Intervention
A single intra-articular injection in the target knee of PTP-001 200 mg.
Group II: PTP-001 100 mgExperimental Treatment1 Intervention
A single intra-articular injection in the target knee of PTP-001 100 mg.
Group III: Placebo/salinePlacebo Group1 Intervention
A single intra-articular injection in the target knee of 4mL of placebo control - physiological saline (0.9% sodium chloride injection, USP).

Find a Location

Who is running the clinical trial?

NBCD A/SIndustry Sponsor
8 Previous Clinical Trials
1,690 Total Patients Enrolled
6 Trials studying Osteoarthritis
1,143 Patients Enrolled for Osteoarthritis
Bioventus LLCLead Sponsor
16 Previous Clinical Trials
15,038 Total Patients Enrolled
10 Trials studying Osteoarthritis
1,525 Patients Enrolled for Osteoarthritis
Moin Khan, MDPrincipal InvestigatorMcMaster University Department of Surgery St. Joseph's Healthcare Hamilton
4 Previous Clinical Trials
308 Total Patients Enrolled
1 Trials studying Osteoarthritis
50 Patients Enrolled for Osteoarthritis

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?
Louisiana
Pennsylvania
How old are they?
18 - 65
65+
What site did they apply to?
Hamilton Medical Research Group
Canadian Phase Onward Inc.
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Canadian Phase Onward Inc.: < 48 hours
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
Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis
2021. "Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05100225.
All > Knee Osteoarthritis
~60 spots leftby Apr 2025
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