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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
St. Nikolaus-Stiftshospital GmbH	Andernach	Germany
GFO Kliniken Niederrhein – St. Vinzenz Hospital Dinslaken	Dinslaken	Germany

Other Sites

Site Name	City	Country
Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gGmbH	Bamberg	Germany
Kjneijau Asuvgcrpjom Lzlq Gvtw	Altenburg	Germany
Ecmlgpmizoxdg Wdpcxkbnczcjpmr Sqzoesp Kfzyzqdfhjugudnjrdz gkpeb	Berlin	Germany
Mshqjzrpcjqopuesidog Ghqflh	Greven	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.04.2025

Trial locations

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.

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 ID:

2024-517684-23-00

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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

What is this study about?

Who Can Join the Study?

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