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

NCT03101163 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: KLSMC-003
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

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).

Conditions

Articular Cartilage Disorder of Knee; Articular Cartilage; Degeneration

Outcome Measures

Primary Outcomes (2)

• International Knee Documentation Committee (IKDC) score

  Subjective IKDC core as a measure of joint function

  24 months

• Knee injury and Osteoarthritis Outcome (KOOS) pain subdomain

  KOOS pain subdomain score as a measure of joint pain

  24 months

Secondary Outcomes (1)

• Numeric Rating Scale (NRS) for pain

  24 months

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  up to 24 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Biological: Autologous peripheral blood stem cells and hyaluronic acid

Standard treatment

ACTIVE COMPARATOR

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

Other: Hyaluronic acid

Interventions

Autologous peripheral blood stem cells and hyaluronic acid BIOLOGICAL

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

Intervention

Hyaluronic acid OTHER

Regimen of intra-articular HA injections and postoperative physiotherapy

Standard treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• KLSMC Stem Cells, Inc.: lead

Study Sites (2)

Andrews Research & Education Foundation (AREF)

Gulf Breeze, Florida, 32561, United States

Location

Kuala Lumpur Sports Medicine Centre

Kuala Lumpur, Malaysia

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 4, 2017
• Study Start: December 1, 2015
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-03

Locations

US (1); MY (1)