Status:
UNKNOWN
Autologous Mesenchymal Stem Cells vs. Chondrocytes for the Repair of Chondral Knee Defects
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Conditions:
Articular Cartilage Lesion of the Femoral Condyle
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of our study is to compare the safety and effectiveness of the use of autologous cultured adipose tissue-derived stem cells versus cultured autologous chondrocytes for the treatment of c...
Detailed Description
Chondral knee lesions are frequent and produce important functional limitations and arthrosis development. Arthrosis is one of the most important causes of disability and its treatment with prosthetic...
Eligibility Criteria
Inclusion
- Symptomatic focal articular cartilage lesion on the medial femoral condyle
- Lesion on femoral condyle between 1 and 5 cm²
- ICRS Grade III/IV
- Stable knee
- Signed patient informed consent
Exclusion
- Clinically relevant member malalignment (\> 5 degrees)
- Non stable knee
- Inflammatory joint disease
- Knee surgery in the last year (transplant, suture or resection of the meniscus, mosaicplasty, microfracture)
- Participation in concurrent trials or in the previous 3 months
- Subjects with hepatitis, HIV or syphilis
- Malignancy in the previous 5 years
- Alcohol and/or drug abuse
- Poor general health as judged by Investigator
- Clinically relevant second cartilage lesion on the patella
- Patellofemoral cartilage lesion
- Known allergy to gentamicin or penicillins (or presence of multiple severe allergies)
- Having received hyaluronic acid intra-articular injections in the affected knee within the last 6 months of baseline
- Taking specific OA drugs such as chondroitin sulfate, diacerein, n-glucosamine, piascledine, capsaicin within 2 weeks of the baseline visit
- Corticosteroid treatment by systemic or intra-articular route within the last month of baseline or intramuscular or oral corticosteroids within the last 2 weeks of baseline
- Chronic use of anticoagulants
- Uncontrolled diabetes
- Any concomitant painful or disabling disease of the spine,hips or lower limbs that would interfere with evaluation of the afflicted knee
- Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
- Liver enzymes (SGOT, SGPT, Alkaline Phosphatase) of more then two times the upper limit of normal or any other result that is clinically important according to the Investigator
- CRP \> 10 mg/l
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01399749
Start Date
September 1 2011
End Date
June 1 2012
Last Update
July 22 2011
Active Locations (1)
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1
La Paz University Hospital. Orthopedic Surgery and Traumatology Department, Knee Unit; Cell Therapy Laboratory.
Madrid, Madrid, Spain, 28046