Articular Cartilage; Degeneration, Articular Cartilage Disorder of Knee
Conditions
Brief summary
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).
Detailed description
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).
Interventions
BIOLOGICALAutologous peripheral blood stem cells and hyaluronic acid
Regimen of intra-articular PBSC and HA injections and postoperative physiotherapy
OTHERHyaluronic acid
Regimen of intra-articular HA injections and postoperative physiotherapy
Sponsors
KLSMC Stem Cells, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 to 55 years at screening (20 to 57 years for the open-label extension) * Present for evaluation and treatment of knee pain, knee swelling, or knee mechanical symptoms due to cartilage lesions * Provide written informed consent * International Cartilage Repair Society (ICRS) Grade 3 or 4 lesions diagnosis from MRI scans of the target knee * All subjects must also satisfy at least 1 of the following inclusion criteria: * Isolated knee articular cartilage lesion (single lesion) estimated to be ≥3 cm2 as demonstrated on MRI scanning. Multiple knee articular cartilage lesions (multiple lesions) with at least 1 lesion estimated to be ≥3 cm2 as demonstrated on MRI scanning. Bipolar cartilage defects demonstrated on MRI scanning with at least 1 articular surface lesion to be ≥3 cm2. One or more cartilage defects involving the patello-femoral joint as demonstrated on MRI scanning with at least 1 lesion ≥3 cm2. One or more cartilage defects involving the tibio-femoral joint as demonstrated on MRI scanning with at least 1 lesion to be ≥3 cm2. Previously failed cartilage repair procedures (i.e., microfracture, osteochondral autograft transplantation surgery (OATS), ACI)
Exclusion criteria
* Three or more previous surgical interventions on the knee in question. * Preoperative flexion deformity greater than 10 degrees. * Presence of ligamentous injury which would require reconstruction, varus or valgus deformity requiring osteotomy, or cases that require complex surgery prior to cartilage regeneration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee (IKDC) score | 24 months | Subjective IKDC core as a measure of joint function |
| Knee injury and Osteoarthritis Outcome (KOOS) pain subdomain | 24 months | KOOS pain subdomain score as a measure of joint pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) for pain | 24 months | Numeric Rating Scale (NRS) for pain |
Other
| Measure | Time frame |
|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | up to 24 months |
Countries
Malaysia, United States
Outcome results
None listed