NCT02439541

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

2.6 years

First QC Date

May 5, 2015

Last Update Submit

March 14, 2016

Conditions

Chronic Ischemic Heart DiseaseHeart FailureAngina

Keywords

cellular therapyChronic ischemic heart diseasephase 1/2 clinical studyhuman umbilical cord mesenchymal stem cellischemic heart diseaseallogeneic stem cell transplantation

Outcome Measures

Primary Outcomes (2)

  • Number and nature of adverse events

    Evidence for new clinical/biological abnormalities.

    Within the first year after intracoronary infusion

  • 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

Secondary Outcomes (4)

  • Exercise Time and Level

    Post cell transplantation: 1, 3, 6, 12 months

  • Quantify myocardium perfusion measured by SPECT

    Post cell transplantation: 6, 12 months

  • Assessment of heart function by left ventricular ejection fraction

    Post cell transplantation: 1, 3, 6，12 months

  • Clinical Improvement in NYHA Classification

    1 year

Study Arms (2)

UCMSC group

EXPERIMENTAL

Patients in this arm received umbilical cord MSCs by intracoronary injection

Biological: UCMSC group

Control group

NO INTERVENTION

Patients in this arm did not receive any intervention.

Interventions

UCMSC groupBIOLOGICAL

Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10\^7)

UCMSC group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe liver or renal dysfunction or hemorrhagic diseases not suitable for PCI.
  • Severe cerebral ischemic stroke or cerebral hemorrhage within 6 month.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences

Beijing, 100071, China

RECRUITING

MeSH Terms

Conditions

Heart FailureAngina PectorisMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bing Liu, M.D

    307-IVY Translational Medicine Center

    STUDY CHAIR

  • Xiaozhong Zhang, M.D

    Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaozhong Zhang, M.D

CONTACT

+86-010-66947136zxz947136@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 8, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

CN(1)