Unique ID issued by UMIN | UMIN000030700 |
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Receipt number | R000034215 |
Scientific Title | Synovial stem cell transplantation for participants who deviate from clinical trial |
Date of disclosure of the study information | 2018/01/16 |
Last modified on | 2019/01/25 11:38:30 |
Synovial stem cell transplantation for participants who deviate from clinical trial
Synovial stem cell transplantation for participants who deviate from clinical trial
Synovial stem cell transplantation for participants who deviate from clinical trial
Synovial stem cell transplantation for participants who deviate from clinical trial
Japan |
meniscus lesions
Orthopedics |
Others
NO
To investigate the safety of autologous synovial stem cell transplantation after meniscus repair
Safety
Adverse event including type, frequency, severity and duration
1) Safety
Device-related adverse event data,including type, frequency,severity and duration
2) Efficacy
Lysholm score,Knee Injury and Osteoarthritis Outcome Score (KOOS),Numerical Rating Scale (NRS)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver | Other |
Transplantation of autologous synovial stem cells after meniscus repair
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients who participated in clinical trial of autologous synovial stem cell transplantation after meniscus repair
2) Patients who were eligible for both shipping inspection and confirmation inspection below
- Sterility test
- Mycoplasma negative test
- Endotoxin test
- Packaging/Display
3) Patients for whom transplantation of autologous synovial stem cell products could not be carried out due to nonconformity for following inspections
- CFU evaluation
- Cell number, viable cell ratio
- Cell purity evaluation
1) Patients with active infection
2) Patient with poor controlled diabetes
3) Patients with complications as shown below and poor general condition.
- Severe cardiovascular disease
- Severe liver disease
- Severe renal dysfunction
- Poor mental illness with poor control
4) Pregnant women, lactating women and patient who may be pregnant, or patient who desires pregnancy during clinical study
5) Patient for whom doctors decide as not appropriate to participate in the clinical study
2
1st name | |
Middle name | |
Last name | Ichiro Sekiya |
Tokyo Medical and Dental University
Center for Stem Cell and Regenerative Medicine
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan
03-5803-4017
sekiya.arm@tmd.ac.jp
1st name | |
Middle name | |
Last name | Office administrator |
Medical Hospital of Tokyo Medical and Dental University
Clinical Research Center
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
03-5803-5612
http://www.tmd.ac.jp/medhospital/topics/
tiken.crc@tmd.ac.jp
Medical Hospital of Tokyo Medical and Dental University
Tokyo Medical and Dental University
Self funding
NO
2018 | Year | 01 | Month | 16 | Day |
Unpublished
Completed
2017 | Year | 12 | Month | 18 | Day |
2018 | Year | 01 | Month | 16 | Day |
2018 | Year | 01 | Month | 05 | Day |
2019 | Year | 01 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034215
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