A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYS™) in Knee Osteoarthritis Patients

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Doron Therapeutics Inc.
Study ID
NCT07219771
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • PTP-01 — BIOLOGICAL
    Allogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline.
  • Placebo control / saline vehicle — OTHER
    The placebo control, physiological saline (0.9% sodium chloride injection, USP), is administered as an intra-articular injection to the target knee.

Study Details

This is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of intra-articular administration of PTP-001 (MOTYS) for the treatment of knee osteoarthritis. The purpose of the trial is to evaluate the efficacy, safety, and tolerability of a single intra-articular injection of PTP-001 compared to placebo over a 52-week period in participants with radiographic and symptomatic knee OA.

Key Dates

Start date
Oct 14, 2025
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PTP-001 200 mg
    A single intra-articular injection in the target knee of PTP-001 200 mg
  • Placebo Comparator: Placebo / saline vehicle
    A single intra-articular injection in the target knee of 4 mL of placebo control (0.9% sodium chloride injection, USP)

Primary Outcome Measure

Proportion of participants meeting strict responder criteria for improvement in knee function. [ Time Frame: 6 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Central Research Associates, LLC dba Flourish ResearchBirminghamAlabama35205
Baleigh Baker
[email protected]
659-209-5575
Kaylee Harris
[email protected]
659-209-5575
Kenneth Jaffe, MD (PRINCIPAL_INVESTIGATOR)
Horizon Clinical ResearchLa MesaCalifornia91942
Tiffany King
[email protected]
619-456-6012
Scott Hacker, MD (PRINCIPAL_INVESTIGATOR)
Focus Clinical ResearchWest HillsCalifornia91307
Carlos Uribe
[email protected]
818-253-8966
Guillermo Acosta
[email protected]
818-253-8966
Hessam Aazami, MD (PRINCIPAL_INVESTIGATOR)
Conquest Research, LLCWinter ParkFlorida32789
Laura Kelly
[email protected]
407-916-0060
Aanand Patel, MD (PRINCIPAL_INVESTIGATOR)
Chicago Clinical Research Institute, Inc.ChicagoIllinois60607
Saad Syed, MD
[email protected]
312-791-3241
Dennis Levinson, MD (PRINCIPAL_INVESTIGATOR)
Lehigh Center for Clinical ResearchAllentownPennsylvania18104
Melissa Fazio
[email protected]
610-820-0342
Jay Kalawadia, MD (PRINCIPAL_INVESTIGATOR)
Coastal Carolina Research Center, LLDNorth CharlestonSouth Carolina29405
Mary Love
[email protected]
312-878-9477
Shailesh Patel, MD (PRINCIPAL_INVESTIGATOR)
JBR Clinical Research, LLCSalt Lake CityUtah84107
Jenny Hunt
[email protected]
801-261-2000
Mike McCarthy
[email protected]
801-261-2000
Todd Bertoch, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Central Research Associates, LLC dba Flourish Research· Birmingham, ALHorizon Clinical Research· La Mesa, CAFocus Clinical Research· West Hills, CAConquest Research, LLC· Winter Park, FLChicago Clinical Research Institute, Inc.· Chicago, ILLehigh Center for Clinical Research· Allentown, PA

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