Cell Bandage (Mesenchymal Stem Cell Therapy) to Treat Meniscal Tears

• Research type

  Research Study

• Full title

  A Prospective Open-Label Study to Evaluate the Safety of Cell Bandage (Mesenchymal Stem Cells) in the Treatment of Meniscal Tears

• IRAS ID

  98378

• Contact name

  Ashley Blom

• Eudract number

  2010-024162-22

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Research Summary
  The proposed study is a first in man trial (phase I/IIa) of Cell Bandage. The product can be used in patients that have suffered a tear to the meniscal cartilage in their knee. Due to its poor blood supply, these tears do not heal and the torn cartilage is usually removed if it causes symptoms such as locking or giving way. Damage to or removal of meniscal tissue alters the biomechanics of the knee, increases point loading, disrupts synoviaflud lubrication, decreases stability of the knee and predisposes to the development of osteoarthritis in the knee. The primary aim of the study is to establish the safety of Cell Bandage. Ten patients between the ages of 18 and 35 with a symptomatic tear and a magnetic resonance imaging (MRI) confirmed meniscal tear will be recruited. Stem cells will be harvested from the patient??s iliac crest (pelvis) two weeks before knee surgery. These cells will then be matured on a matrix in the laboratory before being placed into the meniscal tear and sutured into place during knee arthroscopy (minimally invasive surgery). Patients will be observed for signs of complications and followed up by means of functional knee scores, pain scores and MRI. Patients will attend at 1 week, 1, 3, 6 and 12 months then annually until 7 years after their operation. Specific complications of interest include chronic pain, arthrofibrosis (stiffness), neurovascular injury, osteonecrosis, inflammation, infection, bleeding and deep vein thrombosis. MRI scans will be performed preoperatively and at 3 months, 6 months and 2 years postoperatively. Patient function and activity will be assessed by means of the Lysholm Score, the Tegner Activity Index, the International Knee Documentation Committee (IKDC) Score and a Visual Analogue Score (VAS) for pain.

  Summary of Results
  The purpose of this study was to investigate a Cell Bandage in treatment of meniscal tears in the knee. The menisci are two wedge-shaped pieces of cartilage in each knee which act as "shock absorbers" between your thighbone and shinbone (femur and tibia). They are tough and rubbery to help cushion the joint and keep it stable. Damage to the meniscus in the knee is a common and important source of knee pain and knee problems.

  Most of the meniscus once it is torn generally does not heal very well. This is mainly because over half of the meniscus does not have a good blood supply. Standard or usual treatment is to cut out the torn part of the meniscus at key-hole surgery or to try to repair areas with enough blood supply.

  The overall objectives of the study were as follows:

  - To evaluate the safety of the Cell Bandage following implantation into the knee of patients with a diagnosed meniscal tear.

  - To evaluate the effectiveness of the Cell Bandage following implantation into the knee of patients with a diagnosed meniscal tear.

  Within the study, patients underwent a surgical procedure in order to implant the cell bandage into the affected knee. Following this, patients were followed up over a period of 7 years following implantation. All patients attended for visits at 1 week (5 to 9 days post surgery), 1 month (3 to 5 weeks post surgery), 3 months (11 to 15 weeks post surgery), 6 months (24 to 28 weeks post surgery), 1 year (48 to 56 weeks post surgery), 2 years (100 to 108 weeks post surgery), 3 years (152 to 160 weeks post surgery), 4 years (204 to 212 weeks post surgery), 5 years (250 to 264 years post surgery), 6 years (308 to 316 weeks post surgery) and 7 years (360 to 368 weeks post surgery).

  During each visit, assessments were conducted to evaluate safety and to assess how effective the cell bandage was in the repair of the meniscal tears. This was assessed through the performance of MRI scans and completion of different types of function tests and questionnaires.

  A total of 5 patients were enrolled into the study and of the 5 patients, 1 completed the study through the 7 year-follow up, and 4 terminated early (1 requested withdrawal and 3 were lost to follow up).

  With respect to the assessment of the objectives of the study, the following outcomes were reported:

  • Overall, the Cell Bandage was considered safe, and well tolerated with no significant changes in the parameters assessed for safety i.e., laboratory safety testing and reported side effects (adverse events).
  • There were no major complications associated with the surgical procedure for implantation and all patients were able to rehabilitate successfully.
  • In terms of effectiveness, at the 2-year follow up period, 2 of the 5 patients required further surgery in order to manage injuries to the treated meniscus and 1 of the 5 patients required surgery on the meniscus in the knee that had not been treated.
  • There was a general reduction in pain and improvement in knee function in patients who received the Cell Bandage. This was demonstrated in patients at the 3-month and 6-month review with all patients reporting less frequent pain in the affected knee at their respective final study visits.
  • The range of motion of the affected knee improved in all patients who received the Cell Bandage.

  In summary, the data gathered during the study was considered sufficient to meet the objectives of the study.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  12/SC/0198

• Date of REC Opinion

  2 May 2012

• REC opinion

  Further Information Favourable Opinion