UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026383 |
|---|---|
| Receipt number | R000030110 |
| Scientific Title | Investigator initiated clinical trial of autologous synovial stem cells for meniscus lesions |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2020/03/05 10:25:10 |
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Basic information
Public title
Investigator initiated clinical trial of autologous synovial stem cells for meniscus lesions
Acronym
Autologous synovial MSCs for meniscus lesions
Scientific Title
Investigator initiated clinical trial of autologous synovial stem cells for meniscus lesions
Scientific Title:Acronym
Autologous synovial MSCs for meniscus lesions
Region
| Japan |
Condition
Condition
meniscus lesions
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of autologous synovial stem cells transplanted on the meniscal lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Lysholm score
Key secondary outcomes
1) Efficacy
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Numerical Rating Scale (NRS)
Knee X-ray examination,
MRI 3D analysis (meniscal thickness, height, width)
MRI analysis of meniscal / cartilage degeneration
2) Safety
Adverse event and device-related adverse event data, including type, frequency, severity and duration
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Transplantation of autologous synovial stem cells on the meniscal lesions.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are aged 20 years or older on the acquisition date of informed consent before clinical study, and who can give a written informed consent
2) Patients with meniscus injuries including radial, vertical flap, horizontal flap, horizontal, degenerative or complex tear and patients with meniscus injuries located in the avascular area
3) Patients with clinical symptoms of meniscus injury, including pain
4) Patients with one or more of the following symptoms in the knee:
-catching sensation
-instability feeling
-limited range of motion
-hydrarthrosis
5) Patients who are indicated for menisectomy of 100 mm2 or larger because of (2) to (4)
Key exclusion criteria
1) Patient who is unidentified
2) Patients who underwent menisectomy or meniscus repair in the affected knee
3) Patients whose clinical symptoms have been sufficiently improved by conservative treatments in the last 3 months
4) Patients with knee malalignment.
5) Patients with a history of trauma in the knee
6) Patients for whom MRI is not indicated because of claustrophobia and so on
7) Patients who have had any intraarticular injections (local anesthetic agent, corticosteroid agent, hyaluronic acid) or arthrocentesis in these 3 months.
8) Patients with active infection
9) Patients diagnosed or suspected as malignant tumor in these 5 years
10) Patients sensitive to antibiotics (penicillin, streptomycin or amphotericin B)
11) Patients sensitive to animal (bovine) origin materials
12) Patients with poor controlled diabetes
13) Patients with a pacemaker
14) Patients with poor general condition with following complication;
-severe cardiovascular disease
-severe liver disorder
-severe kidney dysfunction
-poorly controlled psychiatric disorder
-other diseases which sudden deterioration or aggravation is foreseeable during the study period
15) Pregnant women, lactating women and patient who may be pregnant, or patient who desires pregnancy during clinical study
16) Patient who participated in other clinical trials, patient participating in other clinical studies and patient planning to participate in other clinical studies while participating in this clinical study within 12 weeks before the start of transplantation of cellular product
17) Patient for whom doctors decide as not appropriate to participate in the clinical study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Sekiya |
Organization
Tokyo Medical and Dental University
Division name
Center for Stem Cell and Regenerative Medicine
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4017
sekiya.arm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Office |
| Middle name | |
| Last name | Administrator |
Organization
Tokyo Medical and Dental University, Medical Hospital
Division name
Clinical Research Center
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5612
Homepage URL
http://www.tmd.ac.jp/medhospital/topics/
tiken.crc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University, Medical Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University Hospital of Medicine, Institutional Review Board
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5612
tiken.crc@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医科歯科大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
in preparation for submission
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 21 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 10 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 03 | Day |
Last modified on
| 2020 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030110
