A Study to Evaluate the Safety of Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Pā¦ (NCT06084988) | Clinical Trial Compass
CompletedPhase 1/2
A Study to Evaluate the Safety of Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product StromaForte for the Treatment of Knee Osteoarthritis
United Arab Emirates12 participantsStarted 2023-11-07
Plain-language summary
This open-label, single-arm, phase I/II study in mild-to-moderate stage knee osteoarthritis patients is designed to assess the safety and tolerability of intraarticular human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte. 12 male and/or female patients aged over 18 years will be enrolled. The main questions it aims to answer are:
To assess the safety and tolerability of StromaForte within 24 hours, 4 days ,28 days, 84, and 168 post injection during site visits and post injection by telephone calls. Safety and tolerability will be assessed by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE) which is the Incidence of any treatment-emergent serious adverse events (TE-SAEs).
Eligible patients will receive one dose (50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution (sodium chloride supplemented with human serum albumin) to be given via ultrasoundguided intra-articular injection of human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Willing and able to provide written informed consent and comply with all procedures required by the protocol
ā. Aged \> 18 years at the time of signing the informed consent form
ā. Diagnosed with knee OA according to American College and Rheumatology criteria and showing a stage of a mild to moderate arthritis.
ā. Kellgren-Lawrence radiological classification scale II and III at screening
. Unwilling or unable to perform any of the assessments required by the protocol
ā. Patients with clinically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear
ā. Patients with varus or valgus malalignment \>5 degrees as measured by 4-foot standing antero-posterior radiographs
ā. Patients with a history of a previous subtotal medial or lateral meniscectomy
ā. Patients with a history of septic arthritis in the affected joint
ā. Patients with a history of a prior intra-articular knee fracture