UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029824 |
|---|---|
| Receipt number | R000034074 |
| Scientific Title | Multicenter Study of TCD-51073(E) (Feasibility Study) |
| Date of disclosure of the study information | 2017/11/06 |
| Last modified on | 2024/11/09 10:36:48 |
* 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
Multicenter Study of TCD-51073(E) (Feasibility Study)
Acronym
Feasibility Study of TCD-51073(E)
Scientific Title
Multicenter Study of TCD-51073(E) (Feasibility Study)
Scientific Title:Acronym
Feasibility Study of TCD-51073(E)
Region
| Japan |
Condition
Condition
Severe heart failure due to chronic ischemic heart disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Autologous skeletal myoblast sheet for dose response and tolerability after transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival rate(Cardiac disease related death)
Key secondary outcomes
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
| Other |
Interventions/Control_1
Autologous skeletal myoblast sheet
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)Patients falling under any of the following with regard to the quality of the HeartSheet
1)When it is predicted that skeletal myoblasts do not satisfy the number of transplants assumed
2) In the sheet preparation confirmation test, when deviating from the standing time after sowing the cells
(2) Patient with tissue collection using collection / subculture kit of HeartSheet
(3) Patients who sign written informed consent prior to the clinical study
(4) Patients who are able to undergo all scheduled observations and consent to all details of the observations.
Key exclusion criteria
(1) Patients who do not have sheets
(2) Patients with a history of hypersensitivity to the components of the investigational product.
(3) Patient who can not open-heart surgery.
(4) Patients who are judged to be inappropriate for the study by the investigator or the sub investigators.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | yoshiki |
| Middle name | |
| Last name | sawa |
Organization
Osaka University Hospital
Division name
Cardiovascular surgery
Zip code
5650871
Address
2-15 Yamadaoka, Suita-shi, Osaka, Japan
TEL
06-6879-6090
shiken@hp-crc.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | kazuo |
| Middle name | |
| Last name | tamada |
Organization
Terumo Corporation
Division name
Clinical Development Department
Zip code
1631450
Address
Tokyo Opera City Tower 49F, 3-20-2, Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6742-8500
Homepage URL
Rinshokenkyu_HS@terumo.co.jp
Sponsor or person
Institute
Terumo Corporation
Institute
Department
Personal name
Funding Source
Organization
Terumo Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
-
Address
2-15 Yamadaoka, Suita-shi, Osaka, Japan
Tel
06-6210-8290
shiken@hp-crc.med.osaka-u.ac.jp
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
| 2017 | Year | 11 | Month | 06 | 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
7
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2017 | Year | 11 | Month | 04 | Day |
Last modified on
| 2024 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034074
