This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).
This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Regimen of intra-articular PBSC and HA injections and postoperative physiotherapy
Regimen of intra-articular HA injections and postoperative physiotherapy
Andrews Research & Education Foundation (AREF)
Gulf Breeze, Florida, United States
Kuala Lumpur Sports Medicine Centre
Kuala Lumpur, Malaysia
International Knee Documentation Committee (IKDC) score
Subjective IKDC core as a measure of joint function
Time frame: 24 months
Knee injury and Osteoarthritis Outcome (KOOS) pain subdomain
KOOS pain subdomain score as a measure of joint pain
Time frame: 24 months
Numeric Rating Scale (NRS) for pain
Numeric Rating Scale (NRS) for pain
Time frame: 24 months
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