An Open-Label, Double-Treatment Group Study to Evaluate the Efficacy and Safety of Human Allogeneic Bone-Marrow- Derived Mesenchymal Stromal Cell Product StromaForte Compared With Hyaluronic Acid for the Treatment of Knee Osteoarthritis

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCellcolabs Clinical SPV Limited

About this trial

StromaForte injection for knee OA

Eligibility criteria

Qualifiers

Willing and able to provide written informed consent and comply with all procedures required by the protocol.

Aged ≥ 18 years at the time of signing the informed consent form.

Diagnosed with knee osteoarthritis (OA) based on the criteria established by the American College of Rheumatology, confirmed through radiological images no older than three months.

Grade I to IV osteoarthritis on the Kellgren-Lawrence radiological classification scale.

Disqualifiers

Unwilling or unable to perform any of the assessments required by the protocol.

Mechanically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear.

Varus or valgus malalignment >5 degrees as measured by 4-foot standing antero-posterior radiographs.

History of subtotal medial or lateral meniscectomy performed less than 9 months ago.

Trial design

Treatments tested in this trial

  • Mesenchymal Stem Cells (MSC)
  • Hyaluronic Acid (HA)

Treatment groups

140 Participants
are divided into 2 treatment groups