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Joint repair using an in vitro generated scaffold-free tissue engineerd construct (TEC) derived from autologous synovial mesenchymal stem cells

Joint repair using an in vitro generated scaffold-free tissue engineerd construct (TEC) derived from autologous synovial mesenchymal stem cells - Joint repair by tissue engineerd construct (TEC)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001195
Enrollment
20
Registered
2008-07-01
Start date
2009-12-01
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

Chondral lesions Meniscal lesions

Interventions

Implantation of in vitro generated mesenchymal stem cell (MSC)-based tissue engineered construct (TEC) to chondral or meniscal lesions of the knee.

Sponsors

Department of orthopaedics, Osaka University Graduate School of Medicine
Lead Sponsor
Osaka University Hospital, Medical center for translational Research
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with a symptomatic (including pain, catching, locking, or joint effusion) chondral or meniscal lesion of the knee which is clinically detectable by MRI

Exclusion criteria

Exclusion criteria: Patients with 1) Active local infection 2) Serious complications including malignancies 3) Alchol or drung abuse 4) Rheumatoid arthritis, gout, or pseudo gout 5) Abnormal alignment of lower extremity 6) Chondral lesion with more than 5cm2 7) Meniscal lesion with large defect more than one-third of whole meniscal body 8) Patello-femoral instability 9) Diabetes 10) Renal failure which requires dialysis 11) the medication which could affect chondral metabolosm such as vitamin C or hyaluronan 12) Infectious disease (HIV, HBV, HCV, HTLV, syphilis) 13) Pregnancy 14) Allergy 15) participation in other clinical trials 16)Judged inappropriate with other reason by the project investigators

Design outcomes

Primary

MeasureTime frame
Adverse events (National Cancer Institute-Common Toxicity; NCI-CTC; version 2, JACOG version) Arthoscopic assessment of repaired tissue using ICRS evaluation package (http://www.cartilage.org) for chondral lesions and Horibe score (J Bone Joint Surg Br. 1995; 77:245-9) for meniscal lesions.

Secondary

MeasureTime frame
Periodical assessment of clinical symptoms, evaluation by MRI, histology, activity scales (Lyshlom, Tegnar), and by overall subjective assessment score (Knee Injury and Osteoarthritis Outcome Score; KOOS)

Countries

Japan

Contacts

Public ContactNorimasa Nakamura

Osaka University Center for Advanced Medical Engineering and Informatics

06-6879-3552

Outcome results

None listed

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