Chronic Heart FailurePhase 1JOKERNCT03351400
Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration
A Phase 1 study testing Stem cells administered to participants in people with Chronic Heart Failure and Old Myocardial Infarction, run by Sakakibara Heart Institute at 1 site in Japan.
Trial summary
The purpose of this study is to determine the safety and effectiveness of intracoronary infusion of autologous cardiac stem cells in patients with ischemic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Heart Failure, Old Myocardial Infarction
- What is being tested?
- Stem cells administered to participants
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- 15 Nov 2017to Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult with ability to provide informed consent.
- Left ventricular ejection fraction less than 40% as evidenced by echocardiogram.
- Scheduled for elective surgical revascularization within 2 months.
Who cannot join
- Positive for HBs-Ag, HCV-Ab, HIV-Ab, or tests for syphilis.
- Diabetic HbA1c greater than 8.5%.
- Pregnant women.
- Scheduled for additional interventions including ventriculoplasty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration Trial
The purpose of this study is to determine the safety and effectiveness of intracoronary infusion of autologous cardiac stem cells in patients with ischemic cardiomyopathy.
Read the detailed description
This phase I trial will involve 6 patients suffering from chronic ischemic cardiomyopathy and congestive heart failure, to be compared with historical control subjects. This study will be conducted as a collaborative project between the Sakakibara Heart Institute and the CellBank of Japan. The trial is designed to assess the safety and effectiveness of autologous administration of 1,000,000 c-kit-positive cardiac stem cells (CSCs) via intracoronary route following cultivation. The preliminary eligibility criteria will utilize a left ventricular ejection fraction (LVEF) less than 40% measured by echocardiography. During the coronary artery bypass grafting (CABG) surgery, a part (less than 1 gram) of the right atrial appendage (RAA) will be harvested and frozen. When the LVEF is less than 40% after the CABG surgery, the subject will be enrolled as a candidate for the delivery of CSCs, which will be selected from the RAA tissue and cultured for a few months for expansion. The outcome will be evaluated by adverse events as well as cardiac functions.
- Conditions
- Chronic Heart Failure, Old Myocardial Infarction
- Being tested
- Stem cells administered to participants
- Keywords
- cardiac stem cells, c-kit
- Medical subject headings
- Piebaldism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cells administered to participantsBiological
Patients in this arm will receive intracoronary infusion of 1,000,000 autologous c-kit positive cardiac stem cells.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Stem cells administered to participants Receives: Biological: Stem cells administered to participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring adverse events
Including death, ventricular arrhythmia, bleeding, myocardial infarction, cardiac tumor, brain stroke, peripheral embolism
Measured: 2 years
Secondary outcomes (8)
NYHA classification
Measurement of symptom
Measured: 2 years
Serum NT-proBNP
Measurement of cardiac function
Measured: 2 years
Electrocardiogram
Measurement of arrhythmia
Measured: 2 years
Chest X-ray
Measurement of cardiac function
Measured: 2 years
Cardiopulmonary exercise test
Measurement of cardiopulmonary function
Measured: 2 years
Echocardiogram
Measurement of cardiac function
Measured: 2 years
Magnetic resonance imaging
Measurement of cardiac function
Measured: 2 years
Myocardial scintigraphy
Measurement of myocardial viability
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start15 Nov 2017
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakakibara Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- CellBank of Japan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351400
- Sponsor's protocol ID
- PB3170012
- Acronym
- JOKER
- Status last verified
- Mar 2021
- First submitted
- 14 Nov 2017
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chugh AR, Beache GM, Loughran JH, Mewton N, Elmore JB, Kajstura J, Pappas P, Tatooles A, Stoddard MF, Lima JA, Slaughter MS, Anversa P, Bolli R. Administration of cardiac stem cells in patients with ischemic cardiomyopathy: the SCIPIO trial: surgical aspects and interim analysis of myocardial function and viability by magnetic resonance. Circulation. 2012 Sep 11;126(11 Suppl 1):S54-64. doi: 10.1161/CIRCULATIONAHA.112.092627.
PubMed 22965994
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration Trial
- ClinicalTrials.gov ID
- NCT03351400
- Acronym / sponsor ID
- JOKER / PB3170012
- Conditions
- Chronic Heart Failure, Old Myocardial Infarction
- Keywords
- cardiac stem cells, c-kit
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Sakakibara Heart InstituteUniversity, hospital or other
- Collaborators
- CellBank of Japan
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and effectiveness of intracoronary infusion of autologous cardiac stem cells in patients with ischemic cardiomyopathy.
Detailed description
This phase I trial will involve 6 patients suffering from chronic ischemic cardiomyopathy and congestive heart failure, to be compared with historical control subjects. This study will be conducted as a collaborative project between the Sakakibara Heart Institute and the CellBank of Japan. The trial is designed to assess the safety and effectiveness of autologous administration of 1,000,000 c-kit-positive cardiac stem cells (CSCs) via intracoronary route following cultivation. The preliminary eligibility criteria will utilize a left ventricular ejection fraction (LVEF) less than 40% measured by echocardiography. During the coronary artery bypass grafting (CABG) surgery, a part (less than 1 gram) of the right atrial appendage (RAA) will be harvested and frozen. When the LVEF is less than 40% after the CABG surgery, the subject will be enrolled as a candidate for the delivery of CSCs, which will be selected from the RAA tissue and cultured for a few months for expansion. The outcome will be evaluated by adverse events as well as cardiac functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Biological: Stem cells administered to participantsStem cells administered to participants |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult with ability to provide informed consent.
- Left ventricular ejection fraction less than 40% as evidenced by echocardiogram.
- Scheduled for elective surgical revascularization within 2 months.
Key exclusion criteria (4 listed)
- Positive for HBs-Ag, HCV-Ab, HIV-Ab, or tests for syphilis.
- Diabetic HbA1c greater than 8.5%.
- Pregnant women.
- Scheduled for additional interventions including ventriculoplasty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem cells administered to participantsPatients in this arm will receive intracoronary infusion of 1,000,000 autologous c-kit positive cardiac stem cells. | Biological | Treatment group |
Primary outcome
Monitoring adverse events
Time frame: 2 years
Including death, ventricular arrhythmia, bleeding, myocardial infarction, cardiac tumor, brain stroke, peripheral embolism
8 secondary outcomes
NYHA classification
Time frame: 2 years
Serum NT-proBNP
Time frame: 2 years
Electrocardiogram
Time frame: 2 years
Chest X-ray
Time frame: 2 years
Cardiopulmonary exercise test
Time frame: 2 years
Echocardiogram
Time frame: 2 years
Magnetic resonance imaging
Time frame: 2 years
Myocardial scintigraphy
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Background: PubMed 22965994Chugh AR, Beache GM, Loughran JH, Mewton N, Elmore JB, Kajstura J, Pappas P, Tatooles A, Stoddard MF, Lima JA, Slaughter MS, Anversa P, Bolli R. Administration of cardiac stem cells in patients with ischemic cardiomyopathy: the SCIPIO trial: surgical aspects and interim analysis of myocardial function and viability by magnetic resonance. Circulation. 2012 Sep 11;126(11 Suppl 1):S54-64. doi: 10.1161/CIRCULATIONAHA.112.092627.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stem cells administered to participants in people with Chronic Heart Failure and Old Myocardial Infarction, run by Sakakibara Heart Institute at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring adverse events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03351400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.