Dilated CardiomyopathyPhase 1/2RIMECARDNCT01739777
Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy
A Phase 1/2 study testing ucMSC in people with Dilated Cardiomyopathy, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial summary
The purpose of this study is to determine the safety and clinical effectiveness of umbilical cord mesenchymal cells transplanted by intravenous infusion in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- ucMSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- Dec 2012to Jun 2015
- Phase
- Phase 1/2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic heart failure patients in dilated stages
- Etiologies: dilated cardiomyopathy, chronic hypertensive cardiopathy in dilated stage, chronic coronary cardiopathy in dilated stage
- Ejection fraction ≤ 40%.
- Patients who are stable under optimal medical treatment for a period of at least 3 months prior to randomization
Who cannot join
- Severe or persistent heart failure
- Recurrent myocardial ischemia
- Uncontrolled ventricular tachycardia
- Malignant disease (life expectancy of less than one year)
- Manifest ventricular asynchrony
- Hematologic disease
Show all 10Show fewer
- Recent cerebrovascular disease
- Recent acute coronary syndrome
- Serum creatinine >2.26 mg/dL (200 umol/L)
- Atrial fibrillation without heart rate control in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Randomized-Double Blind Clinical Trial of Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells Transplantation in Heart Failure on Patients With Cardiopathy in Dilated Stage, of Different Etiology
The purpose of this study is to determine the safety and clinical effectiveness of umbilical cord mesenchymal cells transplanted by intravenous infusion in patients with heart failure.
Read the detailed description
Phase I-II Clinical Trial - Safety and efficacy of umbilical cord derived mesenchymal stem cells (ucMSC) in patients with heart failure Randomized, double blind, controlled prospective study in patients with compensated heart failure in dilated phase.
Thirty patients will be selected, who will undergo a strict 3-month followup of ventricular function before being sequentially randomized into two groups: the first group of 15 patients will receive a sole injection of ucMSC and the remaining 15 patients will comprise the control group.
Every patient will maintain their standard treatment of heart failure, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 0-3, 3-6, and 6-12 months.
Clinical results will be analyzed after completion of 12 months of followup.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- ucMSC, Controls
- Keywords
- Heart Failure, Coronary Heart Disease, Adult Stem Cells, Umbilical Progenitor Cells, Umbilical Cord Stem Cells Allogenic, Left Ventricular Function, Intravenous Injection
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ucMSCBiological
Also called Umbilical Cord Mesenchymal Stem Cells
1 million mesenchymal cells per Kg weight injected intravenously in allogenic AB plasma
ControlsOther
Autologous Serum will administrated as placebo
| Study group | Role | What they receive |
|---|---|---|
| ucMSC | Experimental | Umbilical cord derived mesenchymal are injected intravenously to Patients. Receives: Biological: ucMSC |
| Controls | Placebo comparator | Intravenous placebo solution are administrated to Patients. Receives: Other: Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Change in global left ventricular ejection fraction
Measured: 3, 6, 12 months
Secondary outcomes (4)
• Change in functional capacity measured in O2 consumption
Measured: 0, 3, 6, 12 months
• Occurrence of major adverse cardiac event
Measured: 12 months
• Change in high sensitivity C-reactive protein (hs CRP)
Measured: 0, 3, 6, 12 months
• Reduction in level of B-type natriuretic peptide (BNP)
Measured: 0, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dilated CardiomyopathyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Bartolucci, Universidad de los Andes, Chile
- Investigators
- Jorge Bartolucci, Dr., Principal investigator, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739777
- Sponsor's protocol ID
- UANDES-C4C
- Other IDs
- CORFO-11IEI-9766
- Acronym
- RIMECARD
- Status last verified
- Jun 2015
- First submitted
- 29 Nov 2012
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hare JM, Traverse JH, Henry TD, Dib N, Strumpf RK, Schulman SP, Gerstenblith G, DeMaria AN, Denktas AE, Gammon RS, Hermiller JB Jr, Reisman MA, Schaer GL, Sherman W. A randomized, double-blind, placebo-controlled, dose-escalation study of intravenous adult human mesenchymal stem cells (prochymal) after acute myocardial infarction. J Am Coll Cardiol. 2009 Dec 8;54(24):2277-86. doi: 10.1016/j.jacc.2009.06.055.
PubMed 19958962Bartolucci J, Verdugo FJ, Gonzalez PL, Larrea RE, Abarzua E, Goset C, Rojo P, Palma I, Lamich R, Pedreros PA, Valdivia G, Lopez VM, Nazzal C, Alcayaga-Miranda F, Cuenca J, Brobeck MJ, Patel AN, Figueroa FE, Khoury M. Safety and Efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Patients With Heart Failure: A Phase 1/2 Randomized Controlled Trial (RIMECARD Trial [Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy]). Circ Res. 2017 Oct 27;121(10):1192-1204. doi: 10.1161/CIRCRESAHA.117.310712. Epub 2017 Sep 26.
PubMed 28974553
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Randomized-Double Blind Clinical Trial of Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells Transplantation in Heart Failure on Patients With Cardiopathy in Dilated Stage, of Different Etiology
- ClinicalTrials.gov ID
- NCT01739777
- Acronym / sponsor ID
- RIMECARD / UANDES-C4C
- Conditions
- Dilated Cardiomyopathy
- Keywords
- Heart Failure, Coronary Heart Disease, Adult Stem Cells, Umbilical Progenitor Cells, Umbilical Cord Stem Cells Allogenic, Left Ventricular Function, Intravenous Injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Dec 2012 (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 purpose of this study is to determine the safety and clinical effectiveness of umbilical cord mesenchymal cells transplanted by intravenous infusion in patients with heart failure.
Detailed description
Phase I-II Clinical Trial - Safety and efficacy of umbilical cord derived mesenchymal stem cells (ucMSC) in patients with heart failure Randomized, double blind, controlled prospective study in patients with compensated heart failure in dilated phase.
Thirty patients will be selected, who will undergo a strict 3-month followup of ventricular function before being sequentially randomized into two groups: the first group of 15 patients will receive a sole injection of ucMSC and the remaining 15 patients will comprise the control group.
Every patient will maintain their standard treatment of heart failure, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 0-3, 3-6, and 6-12 months.
Clinical results will be analyzed after completion of 12 months of followup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ucMSC | Experimental | Biological: ucMSCUmbilical cord derived mesenchymal are injected intravenously to Patients. |
| Controls | Placebo comparator | Other: ControlsIntravenous placebo solution are administrated to Patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic heart failure patients in dilated stages
- Etiologies: dilated cardiomyopathy, chronic hypertensive cardiopathy in dilated stage, chronic coronary cardiopathy in dilated stage
- Ejection fraction ≤ 40%.
- Patients who are stable under optimal medical treatment for a period of at least 3 months prior to randomization
Key exclusion criteria (10 listed)
- Severe or persistent heart failure
- Recurrent myocardial ischemia
- Uncontrolled ventricular tachycardia
- Malignant disease (life expectancy of less than one year)
- Manifest ventricular asynchrony
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 |
|---|---|---|
| ucMSCAlso: Umbilical Cord Mesenchymal Stem Cells1 million mesenchymal cells per Kg weight injected intravenously in allogenic AB plasma | Biological | ucMSC |
| ControlsAutologous Serum will administrated as placebo | Other | Controls |
Primary outcome
• Change in global left ventricular ejection fraction
Time frame: 3, 6, 12 months
4 secondary outcomes
• Change in functional capacity measured in O2 consumption
Time frame: 0, 3, 6, 12 months
• Occurrence of major adverse cardiac event
Time frame: 12 months
• Change in high sensitivity C-reactive protein (hs CRP)
Time frame: 0, 3, 6, 12 months
• Reduction in level of B-type natriuretic peptide (BNP)
Time frame: 0, 3, 6, 12 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 4 Jun 2015.
- Background: PubMed 19958962Hare JM, Traverse JH, Henry TD, Dib N, Strumpf RK, Schulman SP, Gerstenblith G, DeMaria AN, Denktas AE, Gammon RS, Hermiller JB Jr, Reisman MA, Schaer GL, Sherman W. A randomized, double-blind, placebo-controlled, dose-escalation study of intravenous adult human mesenchymal stem cells (prochymal) after acute myocardial infarction. J Am Coll Cardiol. 2009 Dec 8;54(24):2277-86. doi: 10.1016/j.jacc.2009.06.055.
- Derived from this study: PubMed 28974553Bartolucci J, Verdugo FJ, Gonzalez PL, Larrea RE, Abarzua E, Goset C, Rojo P, Palma I, Lamich R, Pedreros PA, Valdivia G, Lopez VM, Nazzal C, Alcayaga-Miranda F, Cuenca J, Brobeck MJ, Patel AN, Figueroa FE, Khoury M. Safety and Efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Patients With Heart Failure: A Phase 1/2 Randomized Controlled Trial (RIMECARD Trial [Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy]). Circ Res. 2017 Oct 27;121(10):1192-1204. doi: 10.1161/CIRCRESAHA.117.310712. Epub 2017 Sep 26.
- Universidad de los Andes.Link provided by the sponsor.
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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.
Jorge Bartolucci, Dr. principal investigator
Universidad de los Andes, Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ucMSC in people with Dilated Cardiomyopathy, run by Universidad de los Andes, Chile at 1 site in Chile.
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 4 inclusion and 10 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 4 Jun 2015. 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 Chile. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
• Change in global left ventricular ejection fraction (time frame: 3, 6, 12 months). 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 NCT01739777, which also lists 2 linked publications.
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 4 Jun 2015.