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

Primary Purpose

Chronic Heart Failure, Non-ischemic Cardiomyopathy, Non-ischemic Dilated Cardiomyopathy

Status
Completed
Phase
Phase 2
Locations
Kazakhstan
Study Type
Interventional
Intervention
Cardiac catheterization
Intracoronary administration of the umbilical cord-derived mesenchymal stromal cells
Sponsored by
The Research-Clinical Center for Cardiac Surgery and Transplantology LLP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic heart failure, Non-ischemic Cardiomyopathy, Non-ischemic Dilated Cardiomyopathy, Mesenchymal stromal cells, Umbilical cord, Regenerative Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women over 18 years of age, who are registered in the dispensary at the The Research-Clinical Center for Cardiac Surgery and Transplantology;
  • The previously established clinical diagnosis of Dilated cardiomyopathy in the stage III-IV of New York Heart Association classification;
  • Non-ischemic etiology of Dilated cardiomyopathy according to coronary angiography or computed tomography of the heart with contrast;
  • Decreased contractile function of the heart the left ventricular ejection fraction ≤35% according to transthoracic echocardiography and computed tomography of the heart with contrast;
  • Presence of automatic (implantable) cardiac defibrillator;
  • Lack of laboratory and clinical data on dysfunctions or insufficiency of other internal organs;
  • The absence of a history of cancer over the past 5 years and deviations according to the analysis of tumor markers;
  • Signed voluntary informed consent to participate in the study.

Exclusion Criteria:

  • Coronary artery disease, previously undergone cardiac surgery, including stenting of the coronary arteries;
  • The presence of clinically significant valve pathology, blood clots in the cavities of the heart, aneurysms of the left ventricle, hypertrophic, early postpartum, alcoholic or restrictive cardiomyopathy, congenital heart defects and resistant hypertension;
  • A history of stroke in the past 2 years;
  • A history of autoimmune and immunodeficiency diseases;
  • Polyvalent allergy;
  • Decompensation of concomitant chronic diseases;
  • Reception of systemic corticosteroids, cytostatics, immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), as well as drugs that deplete DNA or cytotoxic drugs, the last intake of which was within four weeks before the study;
  • Hepatitis B and / or C, syphilis, HIV-carriage or AIDS;
  • The presence of acute systemic infections requiring targeted antibiotic therapy;
  • A history of untreated peptic ulcer and bleeding from the gastrointestinal tract;
  • The presence of early transferred closed and open craniocerebral injuries that have a clinical manifestation and require specialized treatment;
  • A history of uncontrolled epileptic seizures;
  • Porphyria;
  • The need for hospitalization and treatment in a hospice;
  • Alcohol and drug abuse, lack of permanent residence, severe depression, disorientation, distant living.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Main Group

Control Group

Arm Description

Patients of the main group will undergo cardiac catheterization with intracoronary administration of 1×10 (7) umbilical cord-derived mesenchymal stromal cells and and will continue to receive optimal pharmacological therapy

Patients in the control group will only have cardiac catheterization and will continue to receive optimal pharmacological therapy

Outcomes

Primary Outcome Measures

change in the contractile function of the heart
changes in the ejection fraction of the right and left ventricles evaluated by transthoracic echocardiography and computed tomography
change in the size of the heart
changes in the size of the right and left atrium, end diastolic and end systolic size of the right and left ventricles evaluated by transthoracic echocardiography and computed tomography
change in the volumes of the heart
changes in the volumes of the right and left atrium, end diastolic and end systolic volumes of the right and left ventricles evaluated by transthoracic echocardiography and computed tomography

Secondary Outcome Measures

change in the clinical condition evaluated by the Scale for Heart failure to Optimize Clinical Status
changes in the clinical condition evaluated by the Scale for Heart failure to Optimize Clinical Status (SHOCS). The SHOCS scale consists of 10 points. The maximum possible score is 20, and the minimum is 0. Higher scores indicate a worse or worsening clinical condition, while lower scores or decreasing scores indicate a better clinical condition.
change in the markers of myocardial dysfunction
changes in the markers of myocardial dysfunction of the serum level of amino-terminal pro-brain natriuretic peptide
change in the in the 6-minute walk test
changes in the 6-minute walk test, defined as the changes in the distance of traveled
change in the functional status
change in the functional status according to the New York Heart Association classification
change in the quality of life evaluated by the questionnaire Short Form 12 Healthy Survey
change in the quality of life evaluated by the questionnaire Short Form 12 Healthy Survey (SF-12). The SF 12 questionnaire consists of 12 items. The low level of the quality of life corresponds to estimates of 36-47 points, average of 24-35 points, high of 12-23 points.
change in the quality of life evaluated by the Kansas City Cardiomyopathy Questionnaire
changes in the quality of life evaluated by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is composed of 23 items. The options for the answers are of 1 to 5, 6 or 7 points and the score of each of its dimensions has a theoretical range from 0 to 100, 100 being the best outcome.
change in the quality of life evaluated by the Minnesota Living with Heart Failure Questionnaire
changes in the quality of life evaluated by the Minnesota Living with Heart Failure (MLHF) Questionnaire. The MLHF questionnaire is composed of 21 items. The maximum possible scores being 105 and the minimum 0. Higher scores indicate a worse or worsening quality of life, while lower scores or decreasing scores indicate a better quality of life.

Full Information

First Posted
March 3, 2020
Last Updated
April 27, 2023
Sponsor
The Research-Clinical Center for Cardiac Surgery and Transplantology LLP
Collaborators
State-Financed Health Facility "Samara Regional Medical Center Dinasty"
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1. Study Identification

Unique Protocol Identification Number
NCT04325594
Brief Title
The Application of the Umbilical Cord Mesenchymal Stem Cells in the Complex Treatment of Non-ischemic Heart Failure
Acronym
RegenHeart
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Research-Clinical Center for Cardiac Surgery and Transplantology LLP
Collaborators
State-Financed Health Facility "Samara Regional Medical Center Dinasty"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to optimize the complex treatment of chronic heart failure of non-ischemic etiology by supplementing umbilical cord mesenchymal stem cells to the standard drug therapy.
Detailed Description
The purpose of this study is to optimize the complex treatment of non-ischemic dilated cardiomyopathy by supplementing the standard drug therapy with intracoronary administration of umbilical cord-derived mesenchymal stromal cells. Sixty patients will be selected and randomly divided into the main and control groups in a 1: 1 ratio. Patients of the main group will receive complex treatment based on the addition to the standard drug therapy of intracoronary administration of 10 million mesenchymal stromal cells of the umbilical cord, and patients of the control group will receive only standard drug therapy. Every patient will maintain their standard treatment of chronic 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 0-1,1-3 and 3-6 months. Clinical results will be analyzed after completion of 6 months of followup.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Non-ischemic Cardiomyopathy, Non-ischemic Dilated Cardiomyopathy
Keywords
Chronic heart failure, Non-ischemic Cardiomyopathy, Non-ischemic Dilated Cardiomyopathy, Mesenchymal stromal cells, Umbilical cord, Regenerative Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Main Group
Arm Type
Experimental
Arm Description
Patients of the main group will undergo cardiac catheterization with intracoronary administration of 1×10 (7) umbilical cord-derived mesenchymal stromal cells and and will continue to receive optimal pharmacological therapy
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients in the control group will only have cardiac catheterization and will continue to receive optimal pharmacological therapy
Intervention Type
Procedure
Intervention Name(s)
Cardiac catheterization
Intervention Description
Catheterization of the right and left heart cavities
Intervention Type
Biological
Intervention Name(s)
Intracoronary administration of the umbilical cord-derived mesenchymal stromal cells
Intervention Description
After performing cardiac catheterization, selective coronary angiography will be performed abruptly to assess the condition of the coronary canal by access through the right radial or common femoral artery on the right after 70 U/kg of heparin iv. Then 20 ml of the finished suspension (1×10(7) umbilical cord-derived mesenchymal stromal cells diluted in 20 ml of heparinized saline) will be administrated into the mouth of the left coronary artery (LCA) without occlusion of the vessel with a balloon catheter and without stopping the coronary blood flow. Cell injection will be carried out using a standard 6 Fr catheter for selective coronary angiography with perfusion for 10 minutes at a volume rate of 2 ml/min, thereby introducing 1×10(6) cells per minute
Primary Outcome Measure Information:
Title
change in the contractile function of the heart
Description
changes in the ejection fraction of the right and left ventricles evaluated by transthoracic echocardiography and computed tomography
Time Frame
1,3,6 months
Title
change in the size of the heart
Description
changes in the size of the right and left atrium, end diastolic and end systolic size of the right and left ventricles evaluated by transthoracic echocardiography and computed tomography
Time Frame
1,3,6 months
Title
change in the volumes of the heart
Description
changes in the volumes of the right and left atrium, end diastolic and end systolic volumes of the right and left ventricles evaluated by transthoracic echocardiography and computed tomography
Time Frame
1,3,6 months
Secondary Outcome Measure Information:
Title
change in the clinical condition evaluated by the Scale for Heart failure to Optimize Clinical Status
Description
changes in the clinical condition evaluated by the Scale for Heart failure to Optimize Clinical Status (SHOCS). The SHOCS scale consists of 10 points. The maximum possible score is 20, and the minimum is 0. Higher scores indicate a worse or worsening clinical condition, while lower scores or decreasing scores indicate a better clinical condition.
Time Frame
1,3,6 months
Title
change in the markers of myocardial dysfunction
Description
changes in the markers of myocardial dysfunction of the serum level of amino-terminal pro-brain natriuretic peptide
Time Frame
1, 3 and 6 months
Title
change in the in the 6-minute walk test
Description
changes in the 6-minute walk test, defined as the changes in the distance of traveled
Time Frame
1, 3 and 6 months
Title
change in the functional status
Description
change in the functional status according to the New York Heart Association classification
Time Frame
1, 3 and 6 months
Title
change in the quality of life evaluated by the questionnaire Short Form 12 Healthy Survey
Description
change in the quality of life evaluated by the questionnaire Short Form 12 Healthy Survey (SF-12). The SF 12 questionnaire consists of 12 items. The low level of the quality of life corresponds to estimates of 36-47 points, average of 24-35 points, high of 12-23 points.
Time Frame
1, 3 and 6 months
Title
change in the quality of life evaluated by the Kansas City Cardiomyopathy Questionnaire
Description
changes in the quality of life evaluated by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is composed of 23 items. The options for the answers are of 1 to 5, 6 or 7 points and the score of each of its dimensions has a theoretical range from 0 to 100, 100 being the best outcome.
Time Frame
1, 3 and 6 months
Title
change in the quality of life evaluated by the Minnesota Living with Heart Failure Questionnaire
Description
changes in the quality of life evaluated by the Minnesota Living with Heart Failure (MLHF) Questionnaire. The MLHF questionnaire is composed of 21 items. The maximum possible scores being 105 and the minimum 0. Higher scores indicate a worse or worsening quality of life, while lower scores or decreasing scores indicate a better quality of life.
Time Frame
1, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women over 18 years of age, who are registered in the dispensary at the The Research-Clinical Center for Cardiac Surgery and Transplantology; The previously established clinical diagnosis of Dilated cardiomyopathy in the stage III-IV of New York Heart Association classification; Non-ischemic etiology of Dilated cardiomyopathy according to coronary angiography or computed tomography of the heart with contrast; Decreased contractile function of the heart the left ventricular ejection fraction ≤35% according to transthoracic echocardiography and computed tomography of the heart with contrast; Presence of automatic (implantable) cardiac defibrillator; Lack of laboratory and clinical data on dysfunctions or insufficiency of other internal organs; The absence of a history of cancer over the past 5 years and deviations according to the analysis of tumor markers; Signed voluntary informed consent to participate in the study. Exclusion Criteria: Coronary artery disease, previously undergone cardiac surgery, including stenting of the coronary arteries; The presence of clinically significant valve pathology, blood clots in the cavities of the heart, aneurysms of the left ventricle, hypertrophic, early postpartum, alcoholic or restrictive cardiomyopathy, congenital heart defects and resistant hypertension; A history of stroke in the past 2 years; A history of autoimmune and immunodeficiency diseases; Polyvalent allergy; Decompensation of concomitant chronic diseases; Reception of systemic corticosteroids, cytostatics, immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), as well as drugs that deplete DNA or cytotoxic drugs, the last intake of which was within four weeks before the study; Hepatitis B and / or C, syphilis, HIV-carriage or AIDS; The presence of acute systemic infections requiring targeted antibiotic therapy; A history of untreated peptic ulcer and bleeding from the gastrointestinal tract; The presence of early transferred closed and open craniocerebral injuries that have a clinical manifestation and require specialized treatment; A history of uncontrolled epileptic seizures; Porphyria; The need for hospitalization and treatment in a hospice; Alcohol and drug abuse, lack of permanent residence, severe depression, disorientation, distant living.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aziz Azkhojayev, MD
Organizational Affiliation
The Research-Clinical Center for Cardiac Surgery and Transplantology LLP
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Research-Clinical Center for Cardiac Surgery and Transplantology LLP
City
Taraz
State/Province
Zhambyl
ZIP/Postal Code
080000
Country
Kazakhstan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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