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The clinical study for the joint treatment by allogeneic cell sheet

The clinical study for the joint treatment by allogeneic cell sheet - The clinical study for the joint treatment by allogeneic cell sheet

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015205
Enrollment
10
Registered
2014-10-01
Start date
2016-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cartilage defects associated with osteoarthritis of the knee

Interventions

Chondrocytes isolated from samples obtained at polydactyly surgery are passaged in culture as allogeneic cells and then cryopreserved. From the cryopreserved samples, cells which have been verified fo

Sponsors

Tokai University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Cartilage defects under arthroscopy must be greater than or equal to Outerbridge classification Grade III. In addition, the patellofemoral joint and/or the 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 indicated for marrow stimulation techniques or osteochondral autografts.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Frequency and content of adverse events.

Secondary

MeasureTime frame
Clinical evaluation, X-ray, MRl, Arthroscopy, Photoacoustic evaluation, and Pathological evaluation.

Countries

Japan

Contacts

Public ContactMasato Sato

Tokai University School of Medicine Surgical Science, Department of Orthopaedic Surgery

sato-m@is.icc.u-tokai.ac.jp0463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026