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Study of BP CC 001 stem cells from umbilical cord tissue for treating knee cartilage damage

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating cartilage damage in the knee joint using a new medical product called BP CC 001. This product contains special cells called mesenchymal stem cells that are obtained from umbilical cord tissue. These cells are applied during surgery using a supportive structure called Chondro-Gide, which helps them stay in place in the damaged area of the knee.

The purpose of this study is to evaluate how safe and effective this new treatment is for repairing damaged knee cartilage. The treatment involves placing a specific amount of stem cells (10 million cells in 1 milliliter of solution) directly into the damaged area of the knee joint. This is done through a surgical procedure where the cells are carefully applied to the affected area.

During the study, patients will be monitored for two years after their surgery. Doctors will check how well the knee is healing and if there are any side effects from the treatment. They will evaluate various aspects of knee function, including pain levels, daily activities, and the quality of the newly formed cartilage tissue. Regular check-ups will help determine if the treatment is working as intended and ensure patient safety throughout the study period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation and preparation

    Your knee joint cartilage damage will be assessed to confirm it meets the required criteria: grade III/IV cartilage defect or osteochondral defect up to 3mm deep, with a size between 2-6 cm²

    The affected knee will be evaluated using the KOOS pain score (a standardized measure of knee pain)

    Basic health measurements will be taken, including confirmation that your BMI is below 35

  2. Step 2

    Surgical procedure

    You will undergo a surgical procedure where BP CC 001 (a suspension containing 10 million specialized cells) will be applied

    The cells will be placed on a special supporting structure called Chondro-Gide® and inserted into the knee joint

    The procedure will be performed through an intra-articular (inside the joint) approach

  3. Step 3

    Follow-up period - first year

    Your knee will be monitored for any changes or reactions for 12 months after the surgery

    Regular assessments will measure your knee pain levels and daily activities

    Medical imaging will be performed to evaluate cartilage healing using the MOCART score

    Your ability to perform daily activities and exercise will be evaluated using standardized questionnaires

  4. Step 4

    Extended follow-up - second year

    Monitoring will continue for an additional 12 months (total 24 months after surgery)

    Regular evaluations will continue to assess knee pain, function, and quality of life

    Any changes in your knee's condition will be documented

    Final assessments will measure the long-term outcomes of the procedure

Who can join the trial?

8 criteria

  • You must be between 18 and 60 years old, any gender can participate
  • You must have a symptomatic cartilage damage in your knee (classified as grade 3 or 4 according to medical standards) or damage that affects both cartilage and bone up to 3 mm deep
  • The damaged area in your knee must be between 2 to 6 square centimeters in size, located on specific parts of the knee (femoral condyles, patella, or trochlea - the areas where your bones meet in the knee joint)
  • Your knee arthritis severity must be mild to moderate (less than grade 3 on the Kellgren-Lawrence scale) in both the affected knee and the opposite knee
  • When not taking pain medication for 24 hours, your knee pain score must be:
    • 70 or less out of 100 in the affected knee
    • Greater than 80 out of 100 in the opposite knee
    • Your body mass index (BMI) must be less than 35 kg/m²
    • You must provide written informed consent to participate in the study

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 50 years
  • Pregnancy or breastfeeding women
  • Previous surgery on the affected knee within the last 6 months
  • Active joint infection in the knee
  • Severe osteoarthritis (widespread joint damage and wear)
  • Autoimmune diseases affecting joints (conditions where the immune system attacks healthy tissue)
  • Current cancer or history of cancer in the last 5 years
  • Severe obesity with BMI (Body Mass Index) above 35
  • Uncontrolled diabetes (unstable blood sugar levels)
  • Blood disorders or taking blood-thinning medications
  • Active infections or fever
  • Allergies to collagen or materials used in the treatment
  • Participation in other clinical trials within the last 30 days
  • Severe knee deformity or misalignment
  • Inflammatory joint diseases like rheumatoid arthritis (chronic joint inflammation)
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Investigated drugs

  • BP CC 001

    is an investigational therapy that uses mesenchymal stem cells (MSC) derived from umbilical cord tissue. These cells are designed to help repair damaged cartilage in the knee joint. The cells are suspended in a special culture solution and are applied during treatment.

  • Chondro-Gide

    is a collagen membrane that acts as a support structure. It serves as a scaffold where the stem cells are placed, helping them stay in the targeted area of the knee joint where cartilage repair is needed.

What is already known about the treatment

  • BP CC 001

    A novel investigational cell therapy product consisting of mesenchymal stem cells derived from umbilical cord tissue (UC-MSC), administered through application to a collagen support structure (Chondro-Gide®) in the knee joint. This product is currently being studied in Phase I/IIa clinical trials for the treatment of cartilage defects in the knee joint, with the primary focus on evaluating its safety and efficacy. The therapy works by utilizing the regenerative properties of stem cells to potentially repair damaged cartilage tissue, with each dose containing 10 million UC-MSCs suspended in 1 ml of cell culture medium.

  • Chondro-Gide®

    A biocompatible collagen membrane that serves as a support structure for cell-based therapies in cartilage repair procedures. This matrix acts as a scaffold for the mesenchymal stem cells, providing a stable environment for cell attachment and growth while protecting the treatment area in the knee joint. The membrane is specifically designed for cartilage regeneration procedures and is used in combination with cell therapies to enhance their therapeutic potential in treating cartilage defects.

Investigated diseases

Cartilage Defect of the Knee Joint – A condition where the smooth cartilage that covers the ends of bones in the knee joint becomes damaged or worn away. The cartilage defect can occur due to injury, wear and tear, or other underlying conditions. This condition affects the protective tissue that allows smooth movement between bones in the knee joint. The damage can range from small cracks to complete tissue loss in certain areas. Over time, the defect can cause roughness in joint movement and may lead to discomfort during physical activities.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-517684-23-00Estimated enrolment55 patientsSponsorBIONCaRT GmbH

sourced from the EU Clinical Trials Register and site verification

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