Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Ischemic Cardiomyopathy

Heart Failure Clinical Trial

— UCMSC-Heart  

Official title:

Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Ischemic Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02439541
• Other study ID #: 307-IVY-SC-001
• 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

Related Conditions & MeSH terms

• Angina
• Cardiomyopathies
• Chronic Ischemic Heart Disease
• Coronary Artery Disease
• Heart Diseases
• Heart Failure
• Ischemia
• Myocardial Ischemia

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