Meniscus InjuryPhase 1NCT03839238
Safety Observation on hESC Derived MSC Like Cell for the Meniscus Injury
A Phase 1 study testing hESC derived MSC like cell in people with Meniscus Injury, run by Tongji Hospital at 1 site in China.
Trial summary
human embryonic stem cell derived mesenchymal stem cells like cell for the meniscus injury, and observe the safety of the cells for meniscus injury Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Meniscus Injury
- What is being tested?
- hESC derived MSC like cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2019to 30 Sep 2020
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade Ⅰ-Ⅱ meniscus injury of knee joint
- The patients who still have the pain of knee joint and/or limitation of the function after accepted 3 months of nonoperative treatment
Who cannot join
- Recent history of lower limb fractures or intra-articular drug injection
- The patients who have meniscus injury of knee joint need the surgical repair
- The patients who have the severe coagulation disorders, cardiopulmonary failure and so on
- The women who are pregnant or nursing
- There are electronic implants such as pacemakers in the body
- The patients who are infected the HIV, the virus of hepatitis or syphilis
Show all 14Show fewer
- The patients who are alcoholism or drug user
- The patients who have vestibular and balance disorders
- The patients with severe cognitive impairment who cannot follow instructions to complete the treatment
- The patients who don't sign the informed consent
- The patients who have tumor
- Immunodeficiency patients
- The patients who have congenital or acquired knee malformation
- Patients or researchers who are participating in other clinical trials believe that other reasons are not appropriate for clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Safety Observation on Human Embryonic Stem Cell (hESC) Derived Mesenchymal Stem Cells(MSC) Like Cell for the Meniscus Injury
human embryonic stem cell derived mesenchymal stem cells like cell for the meniscus injury, and observe the safety of the cells for meniscus injury
Read the detailed description
Three different dosage of human embryonic stem cell derived mesenchymal stem cells like for meniscus injury patients, and observe the safety of the cells for meniscus injury.
- Conditions
- Meniscus Injury
- Being tested
- hESC derived MSC like cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hESC derived MSC like cellBiological
Different dosage of hESC derived MSC like cell for the meniscus injured patients
| Study group | Role | What they receive |
|---|---|---|
| Meniscus Injured patients | Experimental | hESC Derived MSC Like Cell Receives: Biological: hESC derived MSC like cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in number of adverse events based on the National Cancer Institute-Common Terminology Criteria for Adverse Events
Adverse events include：allergic reactions, local reactions or infections at the injection site and muscle or skeletal dysplasia
Measured: 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Secondary outcomes (7)
Ultrasound of knee joint
Ultrasound of knee joint
Measured: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Visual Analog Score for pain（VAS）
VAS is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective pain. The scale range is from 0 to 10, the higher the score, the more severe the pain.
Measured: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Range of knee motion
to use the goniometer to measure the range of knee motion
Measured: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Lysholm Knee Scale
The scale is to assess the function of knee. The scale range is from 0 to 100, the higher the score, the more severe the knee problems. This scale includes 8 items, and the total score is the sum of these 8 items' scores. Individual items are scored differently, using individual scoring scales: 1. limp (0,3,5), 2. support (0,2,5), 3. locking (0,2,6,10,15), 4. instability (0,5,10,15,20,25), 5. pain (0,5,10,15,20,25), 6. swelling (0,2,6,10), 7. stair climbing (0,2,6,10), 8. squatting (0,2,4,5).
Measured: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
MRI of knee
MRI of knee
Measured: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Global posture analysis system
to test the static balance
Measured: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Dynamic balance test
Use the dynamic posture evaluator
Measured: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start4 Jan 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus InjuryStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- Hong Chen, Doctor, Study director, Wuhan TongJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839238
- Sponsor's protocol ID
- Wuhan Tongji Hospital
- Status last verified
- Nov 2018
- First submitted
- 28 Nov 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Observation on Human Embryonic Stem Cell (hESC) Derived Mesenchymal Stem Cells(MSC) Like Cell for the Meniscus Injury
- ClinicalTrials.gov ID
- NCT03839238
- Acronym / sponsor ID
- Wuhan Tongji Hospital
- Conditions
- Meniscus Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 15 Feb 2019 (actual)
- 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.
human embryonic stem cell derived mesenchymal stem cells like cell for the meniscus injury, and observe the safety of the cells for meniscus injury
Detailed description
Three different dosage of human embryonic stem cell derived mesenchymal stem cells like for meniscus injury patients, and observe the safety of the cells for meniscus injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meniscus Injured patients | Experimental | Biological: hESC derived MSC like cellhESC Derived MSC Like Cell |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Grade Ⅰ-Ⅱ meniscus injury of knee joint
- The patients who still have the pain of knee joint and/or limitation of the function after accepted 3 months of nonoperative treatment
Key exclusion criteria (14 listed)
- Recent history of lower limb fractures or intra-articular drug injection
- The patients who have meniscus injury of knee joint need the surgical repair
- The patients who have the severe coagulation disorders, cardiopulmonary failure and so on
- The women who are pregnant or nursing
- There are electronic implants such as pacemakers in the body
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 |
|---|---|---|
| hESC derived MSC like cellDifferent dosage of hESC derived MSC like cell for the meniscus injured patients | Biological | Meniscus Injured patients |
Primary outcome
The change in number of adverse events based on the National Cancer Institute-Common Terminology Criteria for Adverse Events
Time frame: 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Adverse events include：allergic reactions, local reactions or infections at the injection site and muscle or skeletal dysplasia
7 secondary outcomes
Ultrasound of knee joint
Time frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Visual Analog Score for pain（VAS）
Time frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Range of knee motion
Time frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Lysholm Knee Scale
Time frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
MRI of knee
Time frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Global posture analysis system
Time frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Dynamic balance test
Time frame: baseline, 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
Hong Chen, Doctor study director
Wuhan TongJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hESC derived MSC like cell in people with Meniscus Injury, run by Tongji Hospital at 1 site in China.
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 2 inclusion and 14 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 15 Feb 2019. 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 China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
The change in number of adverse events based on the National Cancer Institute-Common Terminology Criteria for Adverse Events (time frame: 1 week, 1 month, 2months and 3 months after the injection of MSC Like Cell). 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 15 Feb 2019.