Large-scale Expansion and Characterization of Mesenchymal Stem Cells for Clinical Application

• Conditions: Knee Injuries
• Interventions: Other: 103024-F

• Registration Number: NCT02375568
• Lead Sponsor: Chin-Hung Chang

Brief Summary

According to many recent research, mesenchymal stem cells (MSC) isolated from synovial membrane and infrapatellar fat pad have higher ex vivo proliferation capacity, multipotency and ability to undergo chondrogenesis.

Based on this concept, the investigators plan to get two removed tissues (synovial membrane and infrapatellar fat pad) from patients who have an operation of total knee replacement. The investigators are going to isolate and expand MSC from these two tissues respectively, and then compare the chondrogenesis ability for clinical application. In the other hand, the investigators plan to build techniques and procedures which comply with "Good Tissue Practices (GTP)"

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Status Verified: 2015-02
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-24
• Last Update Submitted: 2015-02-24
• Study First Posted: 2015-03-02
• Last Update Posted: 2015-03-02
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Patient who have an total knee replacement surgery

Exclusion Criteria

Patient who don't sign the agreement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
103024-F	103024-F	For patients who have an operation of total knee replacement, two removed tissues (synovial membrane and infrapatellar fat pad) will be collected for mesenchymal stem cell isolation.

Primary Outcome Measures

Name	Time	Method
Cell viability ratio of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage	6 months
Percentage expression of cluster differentiation 90,105, 34, 45 surface markers of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage	6 months
Doubling time of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage	6 months

Secondary Outcome Measures

Name	Time	Method
Alcian blue staining of synovial membrane MSC and infrapatellar fat pad MSC	6 months
Tyep II collagen and aggrecan gene expression of synovial membrane MSC and infrapatellar fat pad MSC	6 months

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 Pan-Ciao, Taipei, Taiwan