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Allogeneic Cell Therapy

Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee 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.

Summary

This trial is testing a new treatment where tiny particles from donated placental tissue are injected into the knee to help people with knee osteoarthritis. The goal is to see if this treatment can reduce pain and improve knee function by calming inflammation and aiding tissue repair.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy - Change from pretreatment baseline in the WOMAC pain subscale
Safety - Incidence of local and systemic AEs
Secondary study objectives
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
10 Previous Clinical Trials
2,121 Total Patients Enrolled
7 Trials studying Osteoarthritis
1,629 Patients Enrolled for Osteoarthritis
Bioventus LLCLead Sponsor
16 Previous Clinical Trials
15,021 Total Patients Enrolled
10 Trials studying Osteoarthritis
1,508 Patients Enrolled for Osteoarthritis
Moin Khan, MDPrincipal InvestigatorMcMaster University Department of Surgery St. Joseph's Healthcare Hamilton
4 Previous Clinical Trials
350 Total Patients Enrolled
1 Trials studying Osteoarthritis
50 Patients Enrolled for Osteoarthritis
~50 spots leftby Dec 2025
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