Efficacy and Safety Study of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee

Phase 2

Completed

Conditions: Articular Cartilage Disorder of Knee
Articular Cartilage; Degeneration

Interventions: Biological: Autologous peripheral blood stem cells and hyaluronic acid
Other: Hyaluronic acid

Registration Number: NCT03101163

Lead Sponsor: KLSMC Stem Cells, Inc.

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Autologous peripheral blood stem cells and hyaluronic acid	Subjects randomized to the intervention group will undergo subchondral drilling surgery according to standard protocol, and will also receive a regimen of PBSC and HA intra-articular injections and postoperative physiotherapy.
Standard treatment	Hyaluronic acid	Subjects randomized to the standard treatment-controlled parallel group will receive intra-articular HA injections and a physiotherapy regimen.

Primary Outcome Measures

Name	Time	Method
Knee injury and Osteoarthritis Outcome (KOOS) pain subdomain	24 months	KOOS pain subdomain score as a measure of joint pain
International Knee Documentation Committee (IKDC) score	24 months	Subjective IKDC core as a measure of joint function

Secondary Outcome Measures

Name	Time	Method
Numeric Rating Scale (NRS) for pain	24 months	Numeric Rating Scale (NRS) for pain

Trial Locations

Locations (2): Andrews Research & Education Foundation (AREF)
🇺🇸
Gulf Breeze, Florida, United States
Kuala Lumpur Sports Medicine Centre
🇲🇾
Kuala Lumpur, Malaysia

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Efficacy and Safety Study of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee

Recruitment & Eligibility

Study & Design

Trial Locations

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