UMIN-CTR Clinical Trial

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
Email	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
Email	kinoue-tky@umin.ac.jp

Sponsor
Institute	Avenue Cell Clinic
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036943