Knee InjuriesNCT02386163
Large-scale ex Vivo Expansion and Characterization of Two Kinds of MSC From Knee for Clinical Application
An observational study of Knee Injuries, run by EMO Biomedicine Corporation at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Knee Injuries
- What is being tested?
- MSC from synovial membrane and infrapatellar Fat Pad
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For patients who have an operation of total knee replacement.
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.
About this study
Official title: Large-scale ex Vivo Expansion and Characterization of Synovial Membrane MSC (SM-MSC) and Infrapatellar Fat Pad MSC (IF-MSC) for Clinical Application
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)".
- Conditions
- Knee Injuries
- Being tested
- MSC from synovial membrane and infrapatellar Fat Pad
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC from synovial membrane and infrapatellar Fat PadBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare MSCs from synovial membrane and infrapatellar fat pad
Comparison items include doubling time, phenotype, chondrogenesis and biological activity.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionAug 2015
- Study completionAug 2015
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 (actual)
Sponsor and investigators
- Lead sponsor
- EMO Biomedicine Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Far Eastern Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Chih-Hung Chang, MD, Ph.D, Principal investigator, Far Eastern Memorial HospitalShing-Mou Lee, Study chair, EMO Biomedicine Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386163
- Sponsor's protocol ID
- EMO-IF-MSC-01
- Status last verified
- Sep 2015
- First submitted
- 2 Mar 2015
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 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 MSC (SM-MSC) and Infrapatellar Fat Pad MSC (IF-MSC) for Clinical Application
- ClinicalTrials.gov ID
- NCT02386163
- Acronym / sponsor ID
- EMO-IF-MSC-01
- Conditions
- Knee Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- EMO Biomedicine CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Far Eastern Memorial Hospital
- Study start
- May 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 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 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)".
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For patients who have an operation of total knee replacement.
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 |
|---|---|---|
| MSC from synovial membrane and infrapatellar Fat Pad | Biological | – |
Primary outcome
Compare MSCs from synovial membrane and infrapatellar fat pad
Time frame: 2 months
Comparison items include doubling time, phenotype, chondrogenesis and biological activity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 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.
Chih-Hung Chang, MD, Ph.D principal investigator
Far Eastern Memorial Hospital
Shing-Mou Lee study chair
EMO Biomedicine Corp.
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 EMO Biomedicine Corporation 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: finished, as of the sponsor's last update on 10 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare MSCs from synovial membrane and infrapatellar fat pad (time frame: 2 months). 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 10 Sep 2015.