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Clinical study using allogeneic cells
(cells donated by someone else)

Clinical study

The clinical study for the joint treatment by allogeneic cell sheet

Study duration
May 24, 2016 to up to five years
Target sample size
10 cases
Flowchart of clinical study
Click here for details.
Selection of test subjects

1)Target patients

Patients with traumatic and/or degenerative cartilage defect of the knee joint

2)Selection, exclusion, and stopping criteria of test subjects

(1)Selection criteria

Patients must meet all of the following criteria and have the ability to give informed consent.

  1. ① 20 to 60 years of age, either male or female
  2. ② Have a cartilage defect of the knee joint
  3. ③ Cartilage defect under arthroscopy of greater than or equal to Outerbridge classification Grade III
  4. ④ The patellofemoral joint and condyle of the femur must have a cartilage defect or defects which can be fully covered by allogeneic chondrocyte sheets and which have traditionally been treated by marrow stimulation techniques or osteochondral autografts.

(2)Exclusion criteria

Patients who meet any one or more of the following criteria will be excluded.

  1. ① Obtaining informed consent from the patient is difficult
  2. ② Having complications hindering surgery under general anesthesia or complications affecting knee surgery
  3. ③ Having problematic infectious disease (including testing positive for HBV, HCV, HIV, HTLV, FTA-ABS)
  4. ④ Having rheumatoid arthritis or other systemic inflammatory disease

(3)Stopping criteria

Treatment under clinical study may be stopped for the following reasons, even if informed consent was given.

  1. ① The patient requests the stoppage of the clinical study
  2. ② Complications during surgery that require the surgery to be stopped
  3. ③ Necessity to change planned surgical procedures from intraoperative findings
  4. ④ Revelation of improper diagnosis from intraoperative findings
  5. ⑤ Occurrence of severe complications during surgery
  6. ⑥ Occurrence of severe adverse events
  7. ⑦ Manufacture of chondrocyte sheets not going according to plan
Outcome Assessment
Primary outcomes: Safety (frequency and content of adverse events)
Secondary outcomes: Efficacy (Preop and postop 12 month evaluation of the following: clinical evaluation, X-ray, MRI, arthroscopy, photoacoustic evaluation, and pathological evaluation)

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