UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032564 |
|---|---|
| Receipt number | R000036943 |
| Scientific Title | A prospective study of the effectiveness of mesenchymal stem cell therapy for lymphedema |
| Date of disclosure of the study information | 2018/05/14 |
| Last modified on | 2020/05/13 13:50:56 |
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Basic information
Public title
A prospective study of the effectiveness of mesenchymal stem cell therapy for lymphedema
Acronym
Study of MSC for lymphedema
Scientific Title
A prospective study of the effectiveness of mesenchymal stem cell therapy for lymphedema
Scientific Title:Acronym
Study of MSC for lymphedema
Region
| Japan |
Condition
Condition
Lower limb lymphedema
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of transplant of autologous culutured adipose derived stem cells on secondary lower limb lymphedema.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immediate pre-intervantion and 1, 3, 6 months post intervention
volume of edema
Visual analogue scale (VAS) of pain
Skin stiffness
Adverse event:Clavien-dindo classification
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Female
Key inclusion criteria
Patients of Unilateral lower limb lymphedema
with histerectomy and pelvic lymph node dissection due to cervical and/or uterine cancerwithout radiation therapy.
Key exclusion criteria
Patients with active cancer, deep vein thronbosis and/or lymphedema morphologically classified into hyperplasia.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Inoue |
Organization
Avenue Cell Clinic
Division name
Avenue Cell Clinic
Zip code
1070062
Address
Minami Aoyama 3-18-6, Minato-ku, Tokyo Japan
TEL
0120-382-300
kinoue-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Inoue |
Organization
Avenue Cell Clinic
Division name
Avenue Cell Clinic
Zip code
1070062
Address
Minami Aoyama 3-18-6, Minato-ku, Tokyo Japan
TEL
0120-382-300
Homepage URL
kinoue-tky@umin.ac.jp
Sponsor or person
Institute
Avenue Cell Clinic
Institute
Department
Personal name
Funding Source
Organization
Avenue Cell Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NPO MINS committee
Address
5-20-9-401 Mita, Minato-Ku, Tokyo, JAPAN
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2018 | Year | 05 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Immediate pre-intervantion and 1, 3, 6 months post intervention
volume of edema
Visual analogue scale (VAS) of pain
Skin stiffness
Adverse event:Clavien-dindo classification
Management information
Registered date
| 2018 | Year | 05 | Month | 12 | Day |
Last modified on
| 2020 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036943
