UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025233 |
|---|---|
| Receipt number | R000029023 |
| Scientific Title | Effects of intravenous autologous bone marrow derived mesenchymal stem cells in patients with chronic heart failure |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2023/12/18 09:47:38 |
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Basic information
Public title
Effects of intravenous autologous bone marrow derived mesenchymal stem cells in patients with chronic heart failure
Acronym
Intravenous bone marrow derived mesenchymal stem cells for chronic heart failure
Scientific Title
Effects of intravenous autologous bone marrow derived mesenchymal stem cells in patients with chronic heart failure
Scientific Title:Acronym
Intravenous bone marrow derived mesenchymal stem cells for chronic heart failure
Region
| Japan |
Condition
Condition
chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy and safety of intravenous autologous bone marrow derived mesenchymal stem cells in patients with chronic heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of left ventricular ejection fraction on echocardiography
Key secondary outcomes
change of BNP and high sensitive troponin
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
| Medicine |
Interventions/Control_1
Culture of autologous bone marrow derived mesenchymal stem cells and intravenous injection of cultured cells
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. NYHA II or III, LVEF less than 45%
2. BNP more than 50 pg/ml
3. Receiving medical therapy including ACE inhibitor and be-ta blocker for more than 12 months
Key exclusion criteria
1. Unstable heart failure
2. Patients with unstable angina
3. Current cardiac surgery and device therapy
4. Life expectancy less than 6 months
5. Severe liver and kidney failure
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Yukihito |
| Middle name | |
| Last name | Sato |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Cardiology
Zip code
660-8550
Address
2-17-77, Higashinaniwa-cho, Amagasaki, Hyogo, Japan 660-8550
TEL
06-6480-7000
cardioys@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukihito |
| Middle name | |
| Last name | Sato |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Cardiology
Zip code
660-8550
Address
2-17-77, Higashinaniwa-cho, Amagasaki, Hyogo, Japan 660-8550
TEL
06-6480-7000
Homepage URL
cardioys@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Hyogo Prefectural Amagasaki General Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Hyogo Prefectural Amagasaki General Medical Center
Address
2-17-77, Higashinaniwa-cho, Amagasaki, Hyogo, Japan 660-8550
Tel
06-6480-7000
cardioys@kuhp.kyoto-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
兵庫県立尼崎総合医療センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34568634/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34568634/
Number of participants that the trial has enrolled
5
Results
The procedure did not induce significant changes in vital signs. One patient had an elevated body temperature after 1 day, but recovered spontaneously. Laboratory tests remained normal for 1 month after cell delivery. Computed tomography was performed after 1-2 years, and there was no evidence of malignancy. In this pilot study of patients with reduced LVEF, intravenous MSC delivery had no adverse effects.
Results date posted
| 2023 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Five patients with left ventricular ejection fraction (LVEF) less than 45%
Participant flow
last follow up date: 2019/12/01
Adverse events
none
Outcome measures
The primary endpoint was safety assessment.
The secondary endpoint was long-term efficacy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029023
