Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02439541
Other study ID # 307-IVY-SC-001
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received May 5, 2015
Last updated March 14, 2016
Start date May 2015
Est. completion date December 2018

Study information

Verified date March 2016
Source Affiliated Hospital to Academy of Military Medical Sciences
Contact Xiaozhong Zhang, M.D
Phone +86-010-66947136
Email zxz947136@126.com
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Interventional

Clinical Trial Summary

Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.


Description:

Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with chronic heart ischemia cohort and prospective study.

Forty patients will be selected and divided into two groups according to patients' willingness to stem cell treatment. The patients who are willing to receive stem cell transplantation will receive UC-MSCs by coronary injection. The patients in control group will not receive any intervention.

Every patient will maintain their standard treatment of chronic heart ischemia, 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, 3-6, and 6-12 months.

Clinical results will be analyzed after completion of 12 months of followup.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Age between 18 and 80 y

- No option for PCI or CABG (Angiographies evaluated by an independent interventional cardiologist).

- Maximal tolerable angina and heart failure medication

- NYHA functional classification (I-III)

- Signed informed consent

Exclusion Criteria:

- Severe liver or renal dysfunction or hemorrhagic diseases not suitable for PCI.

- Severe cerebral ischemic stroke or cerebral hemorrhage within 6 month.

- History with malignant disease within 5 y of inclusion or suspected malignity

- Severe heart failure (NYHA functional classification IV)

- Diminished functional capacity for other reasons such as COPD, alcoholic cardiomyopathy, or viral myocarditis

- Clinical significant anemia, leukopenia, leukocytosis,or thrombocythemia

- Clinical significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during treatment

- Patients with reduced immune response or treated with immunosuppressive medication

- Combined with severe infectious diseases

- Pregnant or fertile women

- Socially and mentally disabilities

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
UCMSC group
Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10^7)

Locations

Country Name City State
China Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences Beijing

Sponsors (2)

Lead Sponsor Collaborator
Affiliated Hospital to Academy of Military Medical Sciences Ivy Institute of Stem Cells Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number and nature of adverse events Evidence for new clinical/biological abnormalities. Within the first year after intracoronary infusion Yes
Primary Incidence of major adverse coronary events (MACE) Major adverse coronary events (MACE) were defined as cardiac death, non-fatal myocardial infarction, or rehospitalization for acute coronary syndrome and for congestive heart failure. Within the first year after intracoronary infusion Yes
Secondary Exercise Time and Level Exercise time and level as assessed via six minute walk test. Post cell transplantation: 1, 3, 6, 12 months No
Secondary Quantify myocardium perfusion measured by SPECT The efficacy of UC-MSC treatment was quantified by the differences between the two groups and from baseline to 6 and 12 months in perfusion images, as measured by SPECT. Post cell transplantation: 6, 12 months No
Secondary Assessment of heart function by left ventricular ejection fraction Change in left ventricular ejection fraction was assessed with echocardiography after cell implantation. Post cell transplantation: 1, 3, 6,12 months No
Secondary Clinical Improvement in NYHA Classification The NYHA scale ranges from 1 (best)"Mild- no limitation of physical activity due to heart failure" to 4 (worst) "Severe-Unable to carry out any physical activity without discomfort due to heart failure". 1 year No
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy