UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017890 |
|---|---|
| Receipt number | R000020728 |
| Scientific Title | Enhancement of healing for extruded injured meniscus by transplantation of synovial stem cells after meniscus surgery. |
| Date of disclosure of the study information | 2015/06/12 |
| Last modified on | 2016/12/11 21:14:23 |
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Basic information
Public title
Enhancement of healing for extruded injured meniscus by transplantation of synovial stem cells after meniscus surgery.
Acronym
Enhancement of healing for extruded injured meniscus by transplantation of synovial stem cells after meniscus surgery.
Scientific Title
Enhancement of healing for extruded injured meniscus by transplantation of synovial stem cells after meniscus surgery.
Scientific Title:Acronym
Enhancement of healing for extruded injured meniscus by transplantation of synovial stem cells after meniscus surgery.
Region
| Japan |
Condition
Condition
Knee meniscal tear
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve the clinical results for the extruded injured meniscus, autologous synovial mesenchymalstem cells (MSCs) are transplanted to the knee following meniscus repair with centralization technique. The main purpose of this study is to evaluate the safety of synovial MSCs.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event data, including type, frequency, severity and duration
Key secondary outcomes
1) Safety of the autologous synovial mesenchymal stem cells
2) Subjective score by KOOS and NRS, Observation of knee, Knee functional evaluation by McMurry test and pivot shift test, Lysholm score
3) MRI examination
4) Knee X-ray examination
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
Arthroscopic transplantation of synovial MSCs after meniscus repair with centralization technique
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) Extruded meniscus injury with radial, horizontal, degenerative tear etc. to which meniscal resection is generally indicated
2) Patients with clinical symptoms such as knee joint unstability, limitation in range of motion, hydrarthrosis and pain
3) Patients suitable for surgery
4) Patients to whom meniscal repair is technically possible
5) Patients older than 20 years on the acquisition date of informed consent before clinical study
6) Patients who gave a written informed consent
Key exclusion criteria
1) Patients who didn't give a written informed consent
2) Patients with active infection
3) Patients positive for HIV (HIV-1, 2 Ag, Ab), HBV (HBs Ag), HCV (HCV Ab), or HTLV-1 (HTLV-1 Ab)
4) Patients with active malignant tumors
5) Patients sensitive to antibiotic
6) Pregnant or breast-feeding women
7) Patients with diabetes
8) Patients in bad general physical condition
9) When 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 | |
| Middle name | |
| Last name | Ichiro Sekiya |
Organization
Tokyo Medical and Dental University
Division name
Center for Stem Cell and Regenerative Medicine
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan
TEL
03-5803-4977
sekiya.arm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Office administrator |
Organization
Medical Hospital of Tokyo Medical and Dental University
Division name
Clinical Research Center
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL
03-5803-5612
Homepage URL
tiken.crc@tmd.ac.jp
Sponsor or person
Institute
Medical Hospital of Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 12 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
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
| 2015 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 12 | Day |
Last modified on
| 2016 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020728
