Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Transplantation to Treat Heart Diseases

Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI) Clinical Trial

— CSHSBMMCTTHD  

Official title:

Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Intracoronary Transplantation in Myocardial Infarction and Other Heart Diseases.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01234181
• Other study ID #: SAHZJU CT001
• Secondary ID: SFDA2010
• Status: Not yet recruiting
• Phase: N/A
• First received: November 3, 2010
• Last updated: November 3, 2010
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2010
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study, is to determine the differences of clinical outcomes between hypoxic pre-treatment group and control group in bone marrow stem cell transplantation (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both treatments. Heart failure patients underwent PCI treatment after AMI and with informed consent, are randomized allocation into hypoxic pre-treated BM-SCT group, normoxic pre-treated BM-SCT group, and control group. Cell resuspension is intracoronary injected into patients receiving coronary angiography, IL-6, CRP, TNF and BNP are detected; echocardiography, cardiac MRI and ECT are analyzed to evaluate heart function and alive myocardial cells. Holter's ECG monitor is employed to observe arrhythmia and embolism. We hypothesize that, by receiving hypoxic pre-treated BM-SCT, impaired heart function will be reversed in heart failure patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of acute Myocardial Infarction(within one month);

• Age under 65;

• Infarction related wall motion abnormality on echocardiography;

• Infarction related TIMI flow grades 3 on coronary angiography during cell injection;

• Informed consent;

Exclusion Criteria:

• Active infection, or hematopoietic malignancy;

• Patients have tumor or other lethal diseases;

• Informed refusal

Study Design

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

Related Conditions & MeSH terms

• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI)

Intervention

Procedure:
• Hypoxia-stressed BMSCs transplantation to cure MI
Experimental group: intracoronary injection of 10^7 BMSCs Sham Comparator: inject the same volume saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

References & Publications (1)

Hu X, Yu SP, Fraser JL, Lu Z, Ogle ME, Wang JA, Wei L. Transplantation of hypoxia-preconditioned mesenchymal stem cells improves infarcted heart function via enhanced survival of implanted cells and angiogenesis. J Thorac Cardiovasc Surg. 2008 Apr;135(4):799-808. doi: 10.1016/j.jtcvs.2007.07.071. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart function		one year	No