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

Completed · Phase 2

Conditions studied: Articular Cartilage Disorder of Knee, Articular Cartilage; Degeneration

In brief

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).

Key facts

Study ID

NCT03101163

Run by

KLSMC Stem Cells, Inc.

People needed

120

Starts

2015-12-01

Expected to finish

2022-07-01

Last updated by the study team

2022-08-16

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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
• 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)

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

Where it is running

• Andrews Research & Education Foundation (AREF) — Gulf Breeze, Florida, United States
• Kuala Lumpur Sports Medicine Centre — Kuala Lumpur, Malaysia

Full record on ClinicalTrials.gov

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