Knee InjuriesNCT02375568
Large-scale Expansion and Characterization of Mesenchymal Stem Cells for Clinical Application
An observational study of Knee Injuries, run by Chin-Hung Chang at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Injuries
- What is being tested?
- 103024-F
- How many people
- 6 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient who have an total knee replacement surgery
Who may be able to join
- Patient who have an total knee replacement surgery
Who cannot join
- Patient who don't sign the agreement
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
Pan-Ciao, Taipei, 220
Chih-Hung Chang, Ph. D, 886-2-89667000 ext. 2888, orthocch@mail.femh.org.tw
About this study
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
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)"
- Conditions
- Knee Injuries
- Being tested
- 103024-F
- Keywords
- mesenchymal stem cells
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
103024-FOther
mesenchymal stem cell isolation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 103024-F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell viability ratio of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage
Measured: 6 months
Doubling time of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage
Measured: 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
Measured: 6 months
Secondary outcomes (2)
Alcian blue staining of synovial membrane MSC and infrapatellar fat pad MSC
Measured: 6 months
Tyep II collagen and aggrecan gene expression of synovial membrane MSC and infrapatellar fat pad MSC
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chin-Hung Chang
- Sponsor type
- University, hospital or other
- Collaborators
- EMO Biomedicine Corporation
- Responsible party
- Sponsor-investigator, Chin-Hung Chang, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375568
- Sponsor's protocol ID
- 201405EMO
- Status last verified
- Feb 2015
- First submitted
- 10 Feb 2015
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02375568
- Acronym / sponsor ID
- 201405EMO
- Conditions
- Knee Injuries
- Keywords
- mesenchymal stem cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Chin-Hung ChangUniversity, hospital or other
- Collaborators
- EMO Biomedicine Corporation
- Study start
- May 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 103024-F | – | Other: 103024-FFor 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient who have an total knee replacement surgery
Key inclusion criteria (1 listed)
- Patient who have an total knee replacement surgery
Key exclusion criteria (1 listed)
- Patient who don't sign the agreement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 103024-Fmesenchymal stem cell isolation | Other | 103024-F |
Primary outcome
Cell viability ratio of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage
Time frame: 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
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
2 secondary outcomes
Alcian blue staining of synovial membrane MSC and infrapatellar fat pad MSC
Time frame: 6 months
Tyep II collagen and aggrecan gene expression of synovial membrane MSC and infrapatellar fat pad MSC
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries, run by Chin-Hung Chang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Hung Chang, MD, Ph.D (886-2-89667000 ext. 2888, orthocch@mail.femh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell viability ratio of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.