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

NCT05100225 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2022-07-19

No results posted yet for this study

Summary

Evaluation of safety, tolerability and efficacy of a single intra-articular (IA) injection of PTP-001, an allogeneic placental tissue particulate, in individuals with knee osteoarthritis (OA).

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

PTP-001

Allogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline.

OTHER

Placebo control

The placebo control, physiological saline (0.9% sodium chloride injection, USP), is administered as an intra-articular injection to the target knee.

Sponsors & Collaborators

  • NBCD A/S

    collaborator INDUSTRY

  • Bioventus LLC

    lead INDUSTRY

Principal Investigators

  • Moin Khan, MD · McMaster University Department of Surgery St. Joseph's Healthcare Hamilton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-10-31
Completion
2022-11-30
FDA Drug
Yes

Countries

  • Australia
  • Canada
  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05100225 on ClinicalTrials.gov