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

Knee Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02375568
• Other study ID #: 201405EMO
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2015
• Last updated: February 24, 2015
• Start date: May 2014
• Est. completion date: August 2015

Study information

• Verified date: February 2015
• Source: Far Eastern Memorial Hospital
• Contact: Chih-Hung Chang, MD, Ph.D
• Phone: 886-2-89667000
• Email: orthocch[@]mail.femh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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)"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patient who have an total knee replacement surgery

Exclusion Criteria:

Patient who don't sign the agreement

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Other:
• 103024-F
mesenchymal stem cell isolation

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Pan-Ciao	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Chin-Hung Chang	EMO Biomedicine Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cell viability ratio of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage		6 months	No
Primary	Doubling time of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage		6 months	No
Primary	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	No
Secondary	Alcian blue staining of synovial membrane MSC and infrapatellar fat pad MSC		6 months	No
Secondary	Tyep II collagen and aggrecan gene expression of synovial membrane MSC and infrapatellar fat pad MSC		6 months	No