Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis

Part of paid clinical trials in Houston, Texas.

Sponsor
Celltex Therapeutics Corporation
Study ID
NCT04448106
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Osteoarthritis Shoulder
  • Osteoarthritis, Hip
  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Celltex- AdMSCs — BIOLOGICAL
    Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue

Study Details

This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). The study subjects will be evaluated for disease-associated severity according to symptoms, such as pain, mobility, daily active life, and functions using arthritis society established specific measurement tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and CSS for OA-shoulders).

Key Dates

Start date
Sep 25, 2023
Status verified
Apr 2023
Primary completion
Aug 1, 2024
Completion
Aug 15, 2026

Study Design

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

Arms

  • Experimental: Phase 2 Arm 1 - OA Knee
    50 subjects receive two doses of 2.0-2.86 x 10\^6 cells/kg on days 0 and 6 via intravenous infusion. On day 3, each subject will receive a single dose of 1.0-2.86 x 10\^6 cells/kg via intra-articular injection into the injured joint.
  • Active Comparator: Phase 2 Arm 2 OA Knee
    Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion
  • Experimental: Phase 2 Arm 3 - OA Hip
    50 subjects receive two doses of 2.0-2.86 x 10\^6 cells/kg on days 0 and 6 via intravenous infusion. On day 3, each subject will receive a single dose of 1.0-2.86 x 10\^6 cells/kg via intra-articular injection into the injured joint.
  • Active Comparator: Phase 2 Arm 4 - OA Hip
    Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion
  • Experimental: Phase 2 Arm 5 - OA Shoulder
    50 subjects receive two doses of 2.0-2.86 x 10\^6 cells/kg on days 0 and 6 via intravenous infusion. On day 3, each subject will receive a single dose of 1.0-2.86 x 10\^6 cells/kg via intra-articular injection into the injured joint.
  • Active Comparator: Phase 2 Arm 6 - OA Shoulder
    Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion

Primary Outcome Measure

the frequency and nature of adverse events occurring during the study based on the annualized rate of all AdMSC-associated adverse events (AEs) in all subjects. [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanley C JonesHoustonTexas77098
Sally McGahee, BS
[email protected]
713-590-1000

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By research site
Stanley C Jones· Houston, TX

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