Comparison of BioCart™II With Microfracture for Treatment of Cartilage Defects of the Femoral Condyle
Primary Purpose
Symptomatic Cartilage Defects of the Femoral Condyle
Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BioCart™II
Microfracture
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Cartilage Defects of the Femoral Condyle focused on measuring Microfracture, Cartilage repair, Autologous chondrocyte implantation
Eligibility Criteria
Inclusion Criteria:
- Age 16 to 60 years
- Femoral condyle lesion (medial, lateral or trochlea)
- Single contained lesion
- Symptomatic (moderate to severe pain on VAS)
- Caused by trauma or OCD
- Depth of lesion up to 6 mm
- Size of lesion 1.5-7.5 cm2
- No general bone or cartilage pathology
- No limb mal-alignment (long leg standing X-ray)
- Mechanically stable knee
- Accompanying pathology menisectomy up to 50%
- Willing and able to comply with protocol and undergo vigorous rehabilitation
- Signed informed consent
Exclusion Criteria:
- Multiple cartilage lesions of the knee, other location than femoral condyle (medial, lateral or trochlear), deeper than 6 mm, smaller than 1.5cm2 or greater than 7.5cm2, mild symptoms, caused by reason other than trauma or OCD, unstable knee, accompanying pathology other than 50% menisectomy.
- Hyaluronic acid knee injections in the past 3 months,
- History of chronic bone or cartilage disorder, bilateral knee pain and/or cartilage lesion
- History of any neoplastic disease, or chemotherapy treatment
- Chronic steroid intake, chronic pain medication use for conditions other than the involved knee, use of blood thinners (during the past 10 days prior to enrollment)
- History of allergy or atopic disease, sensitivity to blood products
- Evidence of any significant systemic disease, known coagulopathies or acute injury that might compromise the patient's welfare
- Pregnant or lactating women
- Substance or alcohol abuse
- Microfracture to the affected knee within the previous 2 years
- Participation in concurrent trials
- Participation in previous trials within 3 months
- Malignancy
- Taking specific drugs for osteoarthritis, such as chondroitin sulfate, diacerein, n-glucosamine, piaseledine, or capsaicin within 2 weeks of the baseline visit
- Chronic use of anticoagulants
- Uncontrolled diabetes
- Active joint infection
- Other unstable cardiac and pulmonary disorder
- Liver enzymes (SGOT, SGPT, alkaline phosphatase) of more then two times the upper limit of normal or any other results that in the clinical investigator's mind is important clinically
- Clinical and/or radiographic disease in the indexed affected joint that includes:
- Osteoarthritis or avascular necrosis
- Rheumatoid arthritis or a history of septic or reactive arthritis
- Gout or a history of gout or pseudogout in the affected knee
- Osteochondritis dissecans of the knee with significant bone loss
- Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e >than ICRS grade 2 on the opposing articular surface)
- Associated damage to the underlying subchondral bone requiring an osteochondral graft
- History of secondary arthropathies (i.e. sickle cell disease, Hemochromatosis, or autoimmune disease)
- Receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee conditions
- BMI >40 kg/m2
- Unable to undergo MRI
- Any reasons making the patient a poor candidate in the eyes of the investigator
Sites / Locations
- Tucson Orthopaedic Institute
- Southeastern Orthopedic Center
- Sinai Hospital of Baltimore
- Mount Sinai Medical Center
- University Orthopedics Center
- Sheba Medical Center Tel Hashomer
- Tel Aviv Sourasky Medical Center
- Assaf Harofeh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
BioCart™II treatment
Microfracture procedure
Outcomes
Primary Outcome Measures
Improvement in the Lysholm joint function score of subjects in the BioCart™II study group compared with the MF study group
Secondary Outcome Measures
Improvement in clinical function post implantation/surgery compared to baseline in the study group and compared with the control group, of the following:
IKDC knee score
KOOS questionnaire
ICRS functional status
VAS pain score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00729716
Brief Title
Comparison of BioCart™II With Microfracture for Treatment of Cartilage Defects of the Femoral Condyle
Official Title
Phase II Study to Investigate the Efficacy and Safety of BioCart™II in the Treatment of Symptomatic Cartilage Defects of the Femoral Condyle in Comparison With Microfracture
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProChon Biotech Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
BioCart™II is a novel scaffold seeded with autologous chondrocytes to be used to repair cartilage lesions of the knee. This study is designed to compare the efficacy and safety of BioCart™II treatment compared to microfracture which is the classical method of treatment.
Detailed Description
Full thickness cartilage lesions are typically incapable of self repair, are a source of pain and morbidity and lead to early onset osteoarthritis. A classical method of treatment has been microfracture where holes are drilled in the subchondral bone to allow influx of bone marrow cells which fill and repair the lesion. The resulting repair has been reported to be mixed fibrocartilage which is recognized to be less efficient and durable than hyaline cartilage, the physiological material making up the joint. In autologous chondrocyte implantation, a sample of cartilage is removed from a non-weight bearing region of the joint and the cells are grown and expanded in culture and then returned to the knee to repair the damaged cartilage. For implantation with BioCart™II, the chondrocytes are grown in the presence of proprietary growth factors which maintain the chondrocytes in optimal condition for subsequent repair. For implantation, the cells are seeded on a completely human three dimensional spongelike scaffold which holds the cells in the correct topology to allow for a rapid repair of the damaged joint with true physiological cartilage. BioCart™II is user friendly for the surgeon and patient alike giving it an advantage over other methods for autologous chondrocyte implantation that are in clinical use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Cartilage Defects of the Femoral Condyle
Keywords
Microfracture, Cartilage repair, Autologous chondrocyte implantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
BioCart™II treatment
Arm Title
B
Arm Type
Active Comparator
Arm Description
Microfracture procedure
Intervention Type
Biological
Intervention Name(s)
BioCart™II
Other Intervention Name(s)
Autologous chondrocyte implantation, ACI
Intervention Description
A cartilage biopsy will be harvested from patients during arthroscopy and used for chondrocyte isolation, culture and future implantation. Subjects will also have about 80 ml venous blood drawn for autologous cell culture medium. Two-four weeks following biopsy harvest, BioCart™II will be implanted into the cartilage defect after careful debridement via miniarthrotomy.
Intervention Type
Procedure
Intervention Name(s)
Microfracture
Other Intervention Name(s)
MF
Intervention Description
MF procedure will be carried out according to accepted practice. After careful debridement multiple perforations, or microfractures, are made in the subchondral bone using an awl. The released bone marrow forms a clot at the lesion site which is an enriched environment for new tissue formation. With the subject's consent a cartilage biopsy will be taken (at least 150 mg) and about 80 ml venous blood withdrawn. This will be used for chondrocyte culture and cryopreservation in case a later BioCart™II implantation is required after failure of the microfracture procedure.
Primary Outcome Measure Information:
Title
Improvement in the Lysholm joint function score of subjects in the BioCart™II study group compared with the MF study group
Time Frame
12 months with optional follow up to 5 years
Secondary Outcome Measure Information:
Title
Improvement in clinical function post implantation/surgery compared to baseline in the study group and compared with the control group, of the following:
Time Frame
12 months with optional follow up to 5 years
Title
IKDC knee score
Time Frame
12 months with optional follow up to 5 years
Title
KOOS questionnaire
Time Frame
12 months with optional follow up to 5 years
Title
ICRS functional status
Time Frame
12 months with optional follow up to 5 years
Title
VAS pain score
Time Frame
12 months with optional follow up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 16 to 60 years
Femoral condyle lesion (medial, lateral or trochlea)
Single contained lesion
Symptomatic (moderate to severe pain on VAS)
Caused by trauma or OCD
Depth of lesion up to 6 mm
Size of lesion 1.5-7.5 cm2
No general bone or cartilage pathology
No limb mal-alignment (long leg standing X-ray)
Mechanically stable knee
Accompanying pathology menisectomy up to 50%
Willing and able to comply with protocol and undergo vigorous rehabilitation
Signed informed consent
Exclusion Criteria:
Multiple cartilage lesions of the knee, other location than femoral condyle (medial, lateral or trochlear), deeper than 6 mm, smaller than 1.5cm2 or greater than 7.5cm2, mild symptoms, caused by reason other than trauma or OCD, unstable knee, accompanying pathology other than 50% menisectomy.
Hyaluronic acid knee injections in the past 3 months,
History of chronic bone or cartilage disorder, bilateral knee pain and/or cartilage lesion
History of any neoplastic disease, or chemotherapy treatment
Chronic steroid intake, chronic pain medication use for conditions other than the involved knee, use of blood thinners (during the past 10 days prior to enrollment)
History of allergy or atopic disease, sensitivity to blood products
Evidence of any significant systemic disease, known coagulopathies or acute injury that might compromise the patient's welfare
Pregnant or lactating women
Substance or alcohol abuse
Microfracture to the affected knee within the previous 2 years
Participation in concurrent trials
Participation in previous trials within 3 months
Malignancy
Taking specific drugs for osteoarthritis, such as chondroitin sulfate, diacerein, n-glucosamine, piaseledine, or capsaicin within 2 weeks of the baseline visit
Chronic use of anticoagulants
Uncontrolled diabetes
Active joint infection
Other unstable cardiac and pulmonary disorder
Liver enzymes (SGOT, SGPT, alkaline phosphatase) of more then two times the upper limit of normal or any other results that in the clinical investigator's mind is important clinically
Clinical and/or radiographic disease in the indexed affected joint that includes:
Osteoarthritis or avascular necrosis
Rheumatoid arthritis or a history of septic or reactive arthritis
Gout or a history of gout or pseudogout in the affected knee
Osteochondritis dissecans of the knee with significant bone loss
Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e >than ICRS grade 2 on the opposing articular surface)
Associated damage to the underlying subchondral bone requiring an osteochondral graft
History of secondary arthropathies (i.e. sickle cell disease, Hemochromatosis, or autoimmune disease)
Receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee conditions
BMI >40 kg/m2
Unable to undergo MRI
Any reasons making the patient a poor candidate in the eyes of the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avner Yayon, PhD MD
Organizational Affiliation
ProChon Biotech Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Tucson Orthopaedic Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Southeastern Orthopedic Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029-6754
Country
United States
Facility Name
University Orthopedics Center
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Sheba Medical Center Tel Hashomer
City
Ramat Gan
ZIP/Postal Code
52662
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
18528742
Citation
Nehrer S, Chiari C, Domayer S, Barkay H, Yayon A. Results of chondrocyte implantation with a fibrin-hyaluronan matrix: a preliminary study. Clin Orthop Relat Res. 2008 Aug;466(8):1849-55. doi: 10.1007/s11999-008-0322-4. Epub 2008 Jun 5.
Results Reference
background
PubMed Identifier
19157740
Citation
Domayer SE, Welsch GH, Nehrer S, Chiari C, Dorotka R, Szomolanyi P, Mamisch TC, Yayon A, Trattnig S. T2 mapping and dGEMRIC after autologous chondrocyte implantation with a fibrin-based scaffold in the knee: preliminary results. Eur J Radiol. 2010 Mar;73(3):636-42. doi: 10.1016/j.ejrad.2008.12.006. Epub 2009 Jan 20.
Results Reference
background
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Comparison of BioCart™II With Microfracture for Treatment of Cartilage Defects of the Femoral Condyle
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