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NCT Number: NCT03101163

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

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).

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Key information

Conditions

Articular Cartilage Disorder of Knee Articular Cartilage; Degeneration

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kuala Lumpur Sports Medicine Centre, Kuala Lumpur, Malaysia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous peripheral blood stem cells and hyaluronic acid

Biological

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

Hyaluronic acid

Other

Regimen of intra-articular HA injections and postoperative physiotherapy

Primary outcomes

  1. International Knee Documentation Committee (IKDC) score

    Time frame: 24 months

    Subjective IKDC core as a measure of joint function

  2. Knee injury and Osteoarthritis Outcome (KOOS) pain subdomain

    Time frame: 24 months

    KOOS pain subdomain score as a measure of joint pain

Secondary outcomes

  1. Numeric Rating Scale (NRS) for pain

    Time frame: 24 months

    Numeric Rating Scale (NRS) for pain

Other outcomes

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

    Time frame: up to 24 months

Sponsors and collaborators

Lead sponsor

KLSMC Stem Cells, Inc.

Industry

Registry information

Official study title

Multicenter, Randomized, Open-Label, Standard Treatment-Controlled Parallel Group Phase 2 Study to Evaluate Efficacy and Safety of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells and Hyaluronic Acid Adjuvant Therapy Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee With an Optional Open-Label Extension for the Standard Treatment-Controlled Group

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2017
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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