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

February 24, 2015 updated by: Chin-Hung Chang

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

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)"

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taipei
      • Pan-Ciao, Taipei, Taiwan, 220
        • Recruiting
        • Far Eastern Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient who have an total knee replacement surgery

Description

Inclusion Criteria:

Patient who have an total knee replacement surgery

Exclusion Criteria:

Patient who don't sign the agreement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 103024-F
mesenchymal stem cell isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cell viability ratio of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage
Time Frame: 6 months
6 months
Doubling time of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage
Time Frame: 6 months
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
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Alcian blue staining of synovial membrane MSC and infrapatellar fat pad MSC
Time Frame: 6 months
6 months
Tyep II collagen and aggrecan gene expression of synovial membrane MSC and infrapatellar fat pad MSC
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chin-Hung Chang

Collaborators

EMO Biomedicine Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ANTICIPATED)

August 1, 2015

Study Completion (ANTICIPATED)

August 1, 2015

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (ESTIMATE)

March 2, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2015

Last Update Submitted That Met QC Criteria

February 24, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201405EMO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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