NCT02386163

Brief Summary

According to many researches, 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 TKR (Total Knee Replacement). The investigators are going to isolate and expand MSC from these two tissues respectively, and then compare their characterization and potential for clinical application. In the other hand, the investigators plan to build techniques and procedures which comply with "Good Tissue Practices (GTP)".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

March 2, 2015

Last Update Submit

September 8, 2015

Conditions

Knee Injuries

Outcome Measures

Primary Outcomes (1)

  • Compare MSCs from synovial membrane and infrapatellar fat pad

    Comparison items include doubling time, phenotype, chondrogenesis and biological activity.

    2 months

Interventions

MSC from synovial membrane and infrapatellar Fat PadBIOLOGICAL

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

For patients who have an operation of total knee replacement.

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

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Taiwan, 220, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

MSC from synovial membrane and infrapatellar fat pad

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Chih-Hung Chang, MD, Ph.D

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Shing-Mou Lee

    EMO Biomedicine Corp.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 11, 2015

Study Start

May 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 10, 2015

Record last verified: 2015-09

Locations

TW(1)