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

NCT ID: NCT03101163

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2022-07-31

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).

Conditions

Articular Cartilage Disorder of Knee; Articular Cartilage; Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Autologous peripheral blood stem cells and hyaluronic acid

Intervention Type: BIOLOGICAL

Regimen of intra-articular PBSC and HA injections and postoperative physiotherapy

Standard treatment

Subjects randomized to the standard treatment-controlled parallel group will receive intra-articular HA injections and a physiotherapy regimen.

Group Type: ACTIVE_COMPARATOR

Hyaluronic acid

Intervention Type: OTHER

Regimen of intra-articular HA injections and postoperative physiotherapy

Interventions

Autologous peripheral blood stem cells and hyaluronic acid

Regimen of intra-articular PBSC and HA injections and postoperative physiotherapy

Intervention Type: BIOLOGICAL

Hyaluronic acid

Regimen of intra-articular HA injections and postoperative physiotherapy

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KLSMC Stem Cells, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Andrews Research & Education Foundation (AREF)

Gulf Breeze, Florida, United States

Kuala Lumpur Sports Medicine Centre

Kuala Lumpur, , Malaysia

Countries

United States; Malaysia

Other Identifiers

KLSMC-003

Identifier Type: -

Identifier Source: org_study_id