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Chronic Heart FailurePhase 1/2RegenHeartNCT04325594

The Application of the Umbilical Cord Mesenchymal Stem Cells in the Complex Treatment of Non-ischemic Heart Failure

A Phase 1/2 study testing Intracoronary administration of umbilical cord-derived MSCs in people with Chronic Heart Failure and Non-ischemic Cardiomyopathy, run by The Research-Clinical Center for Cardiac Surgery and Transplantology LLP at 1 site in Kazakhstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this prospective single-arm clinical study was to evaluate the safety and potential efficacy of intracoronary administration of allogeneic umbilical cord-derived mesenchymal stromal cells (MSCs) as an addition to standard medical therapy in patients with chronic non-ischemic heart failure. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intracoronary administration of umbilical cord-derived MSCs
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteKazakhstan
Study dates
1 Mar 2020to 1 Apr 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women aged 18 years and older
  • Registered at the Research-Clinical Center for Cardiac Surgery and Transplantology
  • Established diagnosis of non-ischemic dilated cardiomyopathy (NYHA Class III-IV)
  • Non-ischemic etiology confirmed by coronary angiography or contrast-enhanced cardiac CT
  • Left ventricular ejection fraction (LVEF) ≤ 35% based on echocardiography or cardiac CT
  • Clinical indications for implantation of an implantable cardioverter-defibrillator (ICD), regardless of actual implantation status
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  • No clinical or laboratory signs of dysfunction or insufficiency of other major organs
  • No history of malignancy within the past 5 years and no abnormal tumor markers
  • Signed written informed consent

Who cannot join

  • Ischemic heart disease or prior cardiac surgery, including coronary artery stenting
  • Significant valvular heart disease, intracardiac thrombus, left ventricular aneurysm, hypertrophic, postpartum, alcoholic or restrictive cardiomyopathy, congenital heart defects, or resistant hypertension
  • Stroke within the past 2 years
  • Autoimmune or immunodeficiency disorders
  • Polyvalent allergy
  • Decompensated chronic comorbidities
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  • Use of systemic corticosteroids, cytotoxic or immunosuppressive drugs (e.g., cyclophosphamide, methotrexate, cyclosporine, azathioprine) within 4 weeks before enrollment
  • Positive tests for hepatitis B or C, syphilis, or HIV/AIDS
  • Active systemic infections requiring targeted antibiotic therapy
  • Untreated peptic ulcer disease or history of gastrointestinal bleeding
  • Clinically significant traumatic brain injury requiring treatment
  • Uncontrolled epileptic seizures
  • Porphyria
  • Requirement for hospice-level care
  • Alcohol or drug abuse, lack of permanent residence, severe depression, disorientation, or inability to participate in follow-up

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site

  • The Research-Clinical Center for Cardiac Surgery and Transplantology LLP

    Taraz, Zhambyl, 080000

Other trials in Kazakhstan

About this study

Official title: Optimization of the Complex Treatment of Nonischemic Dilated Cardiomyopathy Due to the Addition to the Standard Drug Therapy of Intracoronary Administration of Umbilical Cord-derived Mesenchymal Stromal Cells

The purpose of this prospective single-arm clinical study was to evaluate the safety and potential efficacy of intracoronary administration of allogeneic umbilical cord-derived mesenchymal stromal cells (MSCs) as an addition to standard medical therapy in patients with chronic non-ischemic heart failure.

Read the detailed description

This prospective, open-label, single-arm clinical trial investigated the safety and potential efficacy of intracoronary administration of allogeneic umbilical cord-derived mesenchymal stromal cells (MSCs) in patients with chronic non-ischemic heart failure.

A total of 30 patients were enrolled. All participants received standard pharmacological therapy and underwent a single intracoronary infusion of 1×10⁷ MSCs delivered into the left coronary artery during routine cardiac catheterization. The primary objective was to assess the safety of the cell therapy over the first 5 days of hospitalization. Secondary outcomes included changes in left ventricular ejection fraction (LVEF), end-diastolic and end-systolic volumes and diameters, serum NT-proBNP levels, NYHA functional class, 6-minute walk test distance, and quality of life indicators (SF-12, KCCQ, MLHFQ) at 1, 3, and 6 months post-infusion.

Although the study was originally registered with a control group and randomization, it was ultimately conducted as a single-arm design due to ethical and logistical constraints in recruitment. All patients received the same intervention, and no allocation or randomization was performed.

While most patients had clinical indications for an implantable cardioverter-defibrillator (ICD) in accordance with international guidelines, not all had the device implanted due to personal refusal of the procedure. Therefore, ICD presence was not required for inclusion in the study.

Although remuscularization of the myocardium was not a predefined endpoint, retrospective analysis revealed post-treatment thickening of the left ventricular posterior wall and interventricular septum in a subset of patients, as observed on cardiac computed tomography. This structural change was associated with improved systolic function and may guide future hypothesis-driven research.

Being tested
Intracoronary administration of umbilical cord-derived MSCs
Keywords
Chronic heart failure, Non-ischemic Cardiomyopathy, Non-ischemic Dilated Cardiomyopathy, Mesenchymal stromal cells, Umbilical cord, Regenerative Medicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intracoronary administration of umbilical cord-derived MSCsBiological

    A suspension of 1×10⁷ umbilical cord-derived mesenchymal stromal cells in 20 ml of heparinized saline was administered by intracoronary infusion into the left coronary artery via a standard 6 Fr catheter over 10 minutes (2 ml/min). The infusion was performed without balloon occlusion or interruption of coronary blood flow.

Study groups in NCT04325594
Study groupRoleWhat they receive
Treatment GroupExperimentalPatients with chronic non-ischemic heart failure received a single intracoronary administration of 1×10⁷ umbilical cord-derived MSCs and continued optimal pharmacological therapy.
Receives: Biological: Intracoronary administration of umbilical cord-derived MSCs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of ischemic and arrhythmic events, abnormal laboratory and ECG findings within 5 days after intracoronary infusion of umbilical cord-derived MSCs [Safety Assessment]

    Safety will be assessed during a 5-day hospitalization period. Cardiac monitoring will be performed during and after intracoronary MSC infusion. Assessment includes incidence of ECG changes (e.g., ST-segment deviation), cardiac enzyme elevations (AST, ALT), local hypokinesia by echocardiography, and occurrence of ventricular arrhythmias. Laboratory evaluations include complete blood count, biochemistry, coagulation, and urinalysis on day 1 and day 5. Immune status will be assessed via neutrophil count and activity. Patients will be monitored in the intensive care unit for the first 24 hours.

    Measured: First 5 days after infusion

Secondary outcomes (5)

  1. Change in left ventricular structure and function

    Changes in left ventricular ejection fraction (LVEF), end-diastolic and end-systolic volumes (EDV/ESV), and end-diastolic and end-systolic diameters (EDD/ESD), assessed by transthoracic echocardiography and cardiac computed tomography.

    Measured: 1, 3, and 6 months

  2. Change in NT-proBNP levels

    Serum levels of NT-proBNP as a biomarker of myocardial dysfunction.

    Measured: 1, 3, and 6 months

  3. Change in 6-minute walk test distance

    Functional capacity evaluated by the distance covered in the 6-minute walk test.

    Measured: 1, 3, and 6 months

  4. Change in NYHA functional class

    Heart failure severity graded by the New York Heart Association classification.

    Measured: 1, 3, and 6 months

  5. Change in quality of life

    Quality of life assessed using the SF-12 Health Survey, Kansas City Cardiomyopathy Questionnaire (KCCQ), and Minnesota Living with Heart Failure Questionnaire (MLHFQ).

    Measured: 1, 3, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2020
  2. Study start1 Mar 2020
  3. Primary completion1 Jan 2023
  4. Study completion1 Apr 2023

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04325594
Sponsor's protocol ID
RCCCT 02-02-2020
Acronym
RegenHeart
Status last verified
Apr 2025
First submitted
3 Mar 2020
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Intracoronary administration of umbilical cord-derived MSCs in people with Chronic Heart Failure and Non-ischemic Cardiomyopathy, run by The Research-Clinical Center for Cardiac Surgery and Transplantology LLP at 1 site in Kazakhstan.

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 9 inclusion and 15 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 20 Apr 2025. 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 Kazakhstan. 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 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?

Incidence of ischemic and arrhythmic events, abnormal laboratory and ECG findings within 5 days after intracoronary infusion of umbilical cord-derived MSCs [Safety Assessment] (time frame: First 5 days after infusion). 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 NCT04325594.

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 20 Apr 2025.

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