Heart FailurePhase 1NCT02387723
CSCC_ASC Therapy in Patients With Severe Heart Failure
A Phase 1 study testing Allogeneic adipose derived stem cells (CSCC_ASC) in people with Heart Failure, run by JKastrup at 1 site in Denmark.
Trial summary
The present aim is to perform at small clinical safety trial in heart failure patients with allogeneic adipose tissue derived mesenchymal stem cells. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Allogeneic adipose derived stem cells (CSCC_ASC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2014to Nov 2015
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30 to 80 years of age
- Signed informed consent
- Chronic stable IHD
- HF (NYHA II-III)
- LVEF ≤45%
- Maximal tolerable angina and heart failure medication
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- Medication unchanged two months prior to inclusion
- Angiography within six months of inclusion
- No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
- Patients who have had PCI or CABG within six months of inclusion must have a new angiography less than one month before inclusion or at least four months after the intervention to rule out early restenosis
- Patients cannot be included until six months after implantation of a cardiac resynchronisation therapy device
Who cannot join
- Heart Failure (NYHA I or IV)
- Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
- Other revascularisation treatment within four months of treatment
- Moderate to severe valvular disease or valvular disease with option for valvular surgery
- Diminished functional capacity for other reasons such as: coronary obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) <1 L/min, moderate to severe claudication or morbid obesity
- Clinical significant anaemia, leukopenia, leukocytosis or thrombocytopenia
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- Clinically significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during cell injections
- Patients with reduced immune response or treated with immunosuppressive medication
- History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma
- Pregnant women
- Other experimental treatment within four weeks of baseline tests
- Participation in another intervention trial
Trial locations and contacts
1 site in 1 country.
Denmark1 site
2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
Copenhagen, 2100
About this study
Official title: Allogeneic Adipose Tissue-derived Stromal/Stem Cell Therapy in Patients With Ischemic Heart Disease and Heart Failure - a Safety Study
The present aim is to perform at small clinical safety trial in heart failure patients with allogeneic adipose tissue derived mesenchymal stem cells.
Read the detailed description
Patients with heart failure will be treated with culture expanded adipose tissue derived mesenchymal stem cells from healthy donors stored in nitrogen until use. The cells will be injected directly into the myocardium using the NOGA XP method.
The patients will be followed for 6 months for safety and efficacy registration.
- Conditions
- Heart Failure
- Being tested
- Allogeneic adipose derived stem cells (CSCC_ASC)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic adipose derived stem cells (CSCC_ASC)Biological
Culture expanded allogeneic adipose derive stem cells (CSCC_ASC)
| Study group | Role | What they receive |
|---|---|---|
| Stem cell therapy | Experimental | Treatment with direct intra-myocardial Injection of 100 million allogeneic adipose derived stem cells (CSCC_ASC) into the heart Receives: Biological: Allogeneic adipose derived stem cells (CSCC_ASC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of patients with serious adverse events and development of tissue antibodies towards donor cells
Registration of number of patients with serious adverse events and development of tissue antibodies towards donor cells used for treatment in a 6 months follow-up period
Measured: 6 months
Secondary outcomes (1)
Cardial efficacy: left ventricle end-systolic volume (LVESV, ml), left ventricular ejection fraction (LVEF, %), end-diastolic volume (ml) and end-systolic mass (g)
The secondary objectives are to demonstrate improvement in in left ventricle end-systolic volume (LVESV, ml), left ventricular ejection fraction (LVEF, %), end-diastolic volume (ml) and end-systolic mass (g) between baseline and follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- JKastrup
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JKastrup, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jens Kastrup, Professor MD, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387723
- Sponsor's protocol ID
- CSCC_ASC1
- Status last verified
- Feb 2016
- First submitted
- 29 Dec 2014
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data can be shared for Scientific collaboration
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Adipose Tissue-derived Stromal/Stem Cell Therapy in Patients With Ischemic Heart Disease and Heart Failure - a Safety Study
- ClinicalTrials.gov ID
- NCT02387723
- Acronym / sponsor ID
- CSCC_ASC1
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- JKastrupUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 13 Mar 2015 (estimated)
- 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 present aim is to perform at small clinical safety trial in heart failure patients with allogeneic adipose tissue derived mesenchymal stem cells.
Detailed description
Patients with heart failure will be treated with culture expanded adipose tissue derived mesenchymal stem cells from healthy donors stored in nitrogen until use. The cells will be injected directly into the myocardium using the NOGA XP method.
The patients will be followed for 6 months for safety and efficacy registration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem cell therapy | Experimental | Biological: Allogeneic adipose derived stem cells (CSCC_ASC)Treatment with direct intra-myocardial Injection of 100 million allogeneic adipose derived stem cells (CSCC_ASC) into the heart |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 30 to 80 years of age
- Signed informed consent
- Chronic stable IHD
- HF (NYHA II-III)
- LVEF ≤45%
Key exclusion criteria (12 listed)
- Heart Failure (NYHA I or IV)
- Acute coronary syndrome with elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
- Other revascularisation treatment within four months of treatment
- Moderate to severe valvular disease or valvular disease with option for valvular surgery
- Diminished functional capacity for other reasons such as: coronary obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) <1 L/min, moderate to severe claudication or morbid obesity
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 |
|---|---|---|
| Allogeneic adipose derived stem cells (CSCC_ASC)Culture expanded allogeneic adipose derive stem cells (CSCC_ASC) | Biological | Stem cell therapy |
Primary outcome
Safety: Number of patients with serious adverse events and development of tissue antibodies towards donor cells
Time frame: 6 months
Registration of number of patients with serious adverse events and development of tissue antibodies towards donor cells used for treatment in a 6 months follow-up period
1 secondary outcome
Cardial efficacy: left ventricle end-systolic volume (LVESV, ml), left ventricular ejection fraction (LVEF, %), end-diastolic volume (ml) and end-systolic mass (g)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Individual participant dataSharing planned: Yes. Data can be shared for Scientific collaboration
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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.
Jens Kastrup, Professor MD study director
Copenhagen University Hospital, Rigshospitalet
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 Allogeneic adipose derived stem cells (CSCC_ASC) in people with Heart Failure, run by JKastrup at 1 site in Denmark.
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 11 inclusion and 12 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: finished, as of the sponsor's last update on 2 Feb 2016. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety: Number of patients with serious adverse events and development of tissue antibodies towards donor cells (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2016.