UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011881 |
|---|---|
| Receipt number | R000013889 |
| Scientific Title | Healing acceleration of repaired meniscus by synovial stem cells "Clinical study to assess the safety and efficacy of transplantation of autologous synovial mesenchymal stem cells in patients with knee meniscal tear" |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2015/10/07 10:37:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Healing acceleration of repaired meniscus by synovial stem cells
"Clinical study to assess the safety and efficacy of transplantation of autologous synovial mesenchymal stem cells in patients with knee meniscal tear"
Acronym
Healing acceleration of repaired meniscus by synovial stem cells
Scientific Title
Healing acceleration of repaired meniscus by synovial stem cells
"Clinical study to assess the safety and efficacy of transplantation of autologous synovial mesenchymal stem cells in patients with knee meniscal tear"
Scientific Title:Acronym
Healing acceleration of repaired meniscus by synovial stem cells
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 of meniscal repair, autologous synovial stem cells are transplanted to the sutured meniscus after meniscal repair in patients with meniscal tear to which meniscal resection is applied at present. The main purpose of this study is to evaluate the safety and efficacy of transplantation of autologous synovial stem cells.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety of clinical research is evaluated on the presence, severity and frequency of adverse events caused by autologous synovial stem cells.
Key secondary outcomes
1) Feasibility of the quality control of cultured synovial stem cells
2) Subjective symptom (KOOS and NRS scores based on patient-oriented evaluation) and knee symptom before and after 4, 6, 12, 24 weeks of meniscal repair.
3) MRI assessment of sutured meniscus before and after 12, 24 weeks of meniscal repair
4) Width of joint space evaluated by X-ray examination before and after 12, 24 weeks of meniscal repair
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
| Device,equipment | Maneuver |
Interventions/Control_1
meniscal repair and transplantation of autologous synovial stem cells to the sutured meniscus
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) Meniscal tear such as radial tear, horizonal flap tear, complex tear and degenerative tear to which meniscal resection is generally applied
2) Patients with clinical symptoms such as knee joint unstability, limitation in range of motion, hydrathrosis and pain
3) Patients approved for treatment with 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, HIV-2), HBV, HCV, or HTLV-1
4) Patients with active malignant tumors
5) Patients with sensitivity to antibiotic
6) Pregnant or breast-feeding women
7) Patients with diabetes
8) Patients in bad general condition
9) Patients evaluated as a contraindication to the clinical study by one's doctor
Target sample size
5
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, 113-8519, 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
http://www.tmd.ac.jp/medhospital/topics/
tiken.crc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
National government
Organization
Division
Category of Funding Organization
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
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
| 2013 | Year | 10 | 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
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
| 2013 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 05 | Month | 18 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 27 | Day |
Last modified on
| 2015 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013889
