Large-scale Expansion and Characterization of Mesenchymal Stem Cells for Clinical Application
Large-scale ex Vivo Expansion and Characterization of Synovial Membrane Mesenchymal Stem Cells (SM-MSC) and Infrapatellar Fat Pad Mesenchymal Stem Cells (IF-MSC) for Clinical Application
1 other identifier
observational
6
1 country
1
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)"
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMarch 2, 2015
February 1, 2015
1.3 years
February 10, 2015
February 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cell viability ratio 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
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
Secondary Outcomes (2)
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
Study Arms (1)
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.
Interventions
Eligibility Criteria
Patient who have an total knee replacement surgery
You may qualify if:
- Patient who have an total knee replacement surgery
You may not qualify if:
- Patient who don't sign the agreement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chin-Hung Changlead
- EMO Biomedicine Corporationcollaborator
Study Sites (1)
Far Eastern Memorial Hospital
Pan-Ciao, Taipei, 220, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD. PhD.
Study Record Dates
First Submitted
February 10, 2015
First Posted
March 2, 2015
Study Start
May 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
March 2, 2015
Record last verified: 2015-02