D017202Phase 1NCT04695522
ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery
A Phase 1 study testing ADR-002K administration in people with D017202, run by Osaka University at 1 site in Japan.
Trial summary
Ischemic cardiomyopathy undergoing coronary artery bypass surgery Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- D017202
- What is being tested?
- ADR-002K administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- 27 Nov 2019to 31 Oct 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are clinically diagnosed with ischemic cardiomyopathy and receive CABG
- Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent
- Others
Who cannot join
- Patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure
- Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator
- Others
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Osaka University Hospital
Suita, Osaka, 5650871
Daisuke Mori, Ph.D, +81-6-6879-3154, daimolion@gmail.com
Masao Sasai, Ph.D, +81-6-6105-5240, sasai-masao@tissue.med.osaka-u.ac.jp
About this study
Official title: Phase I Trial of ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery
Ischemic cardiomyopathy undergoing coronary artery bypass surgery
- Conditions
- D017202
- Being tested
- ADR-002K administration
- Keywords
- Coronary artery bypass, Ischemic cardiomyopathy, Adipose-derived mesenchymal stem cells, Regenerative medicine, Spray method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADR-002K administrationBiological
ADR-002K administration
| Study group | Role | What they receive |
|---|---|---|
| Group of subjects undergoing cell transplantation | Experimental | Not described Receives: Biological: ADR-002K administration |
| Group of subjects undergoing sham operation | Sham comparator | Not described Receives: Biological: ADR-002K administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse event
Safety assessment related to adverse events and this product
Measured: 26 weeks
Amount of change in late gadolinium contrast-enhanced area at the time of screening and 6 months after surgery
Efficacy (Exploratory)
Measured: 26 weeks
Number of complication associated with drug administration method
Feasibility of drug administration method
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start27 Nov 2019
- Primary completion30 Apr 2021 (estimated)
- Study completion31 Oct 2021 (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 D017202Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Rohto Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Daisuke Mori, Osaka University
- Investigators
- Daisuke Mori, Ph.D, Principal investigator, Osaka University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695522
- Sponsor's protocol ID
- CVSR0006
- Status last verified
- Jan 2021
- First submitted
- 9 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kawamura T, Yoshioka D, Kawamura A, Misumi Y, Taguchi T, Mori D, Saito S, Yamauchi T, Hata H, Miyagawa S. Safety and therapeutic potential of allogeneic adipose-derived stem cell spray transplantation in ischemic cardiomyopathy: a phase I clinical trial. J Transl Med. 2024 Dec 2;22(1):1091. doi: 10.1186/s12967-024-05816-1.
PubMed 39623426
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT04695522
- Acronym / sponsor ID
- CVSR0006
- Conditions
- D017202
- Keywords
- Coronary artery bypass, Ischemic cardiomyopathy, Adipose-derived mesenchymal stem cells, Regenerative medicine, Spray method
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Rohto Pharmaceutical Co., Ltd.
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 5 Jan 2021 (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.
Ischemic cardiomyopathy undergoing coronary artery bypass surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of subjects undergoing cell transplantation | Experimental | Biological: ADR-002K administration |
| Group of subjects undergoing sham operation | Sham comparator | Biological: ADR-002K administration |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are clinically diagnosed with ischemic cardiomyopathy and receive CABG
- Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent
- Others
Key exclusion criteria (3 listed)
- Patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure
- Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator
- Others
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 |
|---|---|---|
| ADR-002K administrationADR-002K administration | Biological | Group of subjects undergoing cell transplantation, Group of subjects undergoing sham operation |
Primary outcome
Number of participants with Adverse event
Time frame: 26 weeks
Safety assessment related to adverse events and this product
Amount of change in late gadolinium contrast-enhanced area at the time of screening and 6 months after surgery
Time frame: 26 weeks
Efficacy (Exploratory)
Number of complication associated with drug administration method
Time frame: 26 weeks
Feasibility of drug administration method
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Derived from this study: PubMed 39623426Kawamura T, Yoshioka D, Kawamura A, Misumi Y, Taguchi T, Mori D, Saito S, Yamauchi T, Hata H, Miyagawa S. Safety and therapeutic potential of allogeneic adipose-derived stem cell spray transplantation in ischemic cardiomyopathy: a phase I clinical trial. J Transl Med. 2024 Dec 2;22(1):1091. doi: 10.1186/s12967-024-05816-1.
- Individual participant dataSharing planned: No
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.
Daisuke Mori, Ph.D principal investigator
Osaka University Hospital
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 ADR-002K administration in people with D017202, run by Osaka University 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 3 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 5 Jan 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. Some participants in this study may receive a placebo. 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?
Contact Daisuke Mori, Ph.D (+81-6-6879-3154, daimolion@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse event (time frame: 26 weeks). The study lists 3 primary outcomes in all. 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 NCT04695522, 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 5 Jan 2021.