IMMNC-HF: IntraMyocardial Injection of Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients

Heart Failure Clinical Trial

— IMMNC-HF  

Official title:

Evaluation of the Intramyocardial Injection of Autologous Bone Marrow Derived Mononuclear Stem Cells in Heart Failure (HF) Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03227198
• Other study ID #: SCARM-Heart-002
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 14, 2020
• Est. completion date: October 12, 2021

Study information

• Verified date: August 2020
• Source: SCARM Institute, Tabriz, Iran
• Contact: Nasser Safaie, CTS
• Phone: 0413 33349525
• Email: drsafaie[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess the Evaluation of the intramyocardial injection of autologous bone marrow derived mononuclear stem cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(<=30%) when compared to a control group of patients undergoing best medical care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: October 12, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Men and women of any ethnic origin 18 = aged= 65 years

2. EF=40 (by Echocardiography) and regional wall motion abnormality

3. Not responding to standard therapies

4. the New York Heart Association (NYHA) class = III

5. Myocardial infarction due to coronary artery atherosclerotic disease

6. An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI)

7. Normal liver and renal function

8. No or controlled diabetes

9. Able to give voluntary written consent and understand the study information provided to him

Exclusion Criteria:

1. Participation in another clinical trial within 30 days prior randomisation

2. Previously received stem/progenitor cell therapy

3. Pregnant women

4. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol

5. Cardiogenic shock requiring mechanical support

6. Congenital / valvular heart disease

7. Implantable cardioverter defibrillator (ICD) transplant

8. Platelet count <100.000/µl, or hemoglobin <8.5 g/dl

9. Impaired renal function, i.e. creatinine >2.5 mg/dl

10. Fever or diarrhea within 4 weeks prior screening

11. History of bleeding disorder within 3 months prior screening

12. Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg) or Sustained ventricular arrhythmia

13. Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease

Related Conditions & MeSH terms

• Heart Failure

Intervention

Biological:
• Intramyocardial injection of stem cell
Autologous bone marrow-derived mononuclear cells are obtained from 100-150ml of bone marrow aspirated under local anaesthesia from the iliac crest. Intramyocardial injection of the cells is performed in patients with Heart failure in open heart surgery (CABG)
• Placebo
Injection of Placebo in patients with Heart failure in open heart surgery (CABG)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Stem Cell And Regenerative Medicine institute (SCARM)	Tabriz

Sponsors (1)

Lead Sponsor	Collaborator
SCARM Institute, Tabriz, Iran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	The rate of patients mortality after transplantation	12 months
Primary	Hospitalization	the rate of hospitalization after transplantation	12 months
Secondary	Ejection fraction changes	Elevation of ejection fraction in patients after transplantation	12 months
Secondary	6-minute walk test (6MWT)	Evaluation the improvement of 6MWT test after transplantation	12 months
Secondary	Pro b-type natriuretic peptide (Pro-BNP) changes	Elevation the reduction of Pro-BNP in patients after transplantation	12 months
Secondary	NYHA functional class	Evaluation the improvement of NYHA functional class in patients	12 months