Retrograde Delivery of BMAC (Bone Marrow Aspirate Concentrate) for Congestive Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Harvest Technologies
ClinicalTrials.gov Identifier:
NCT01299324
First received: January 10, 2011
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

The primary objective of this feasibility study is to provide clinical data to demonstrate the safety and activity of a concentrate of nucleated cells from bone marrow aspirate (BMAC) produced with the Harvest Bone Marrow Aspirate Concentrate System for treating patients diagnosed with congestive heart failure (CHF).


Condition Intervention Phase
Congestive Heart Failure
Device: BMAC infusion
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study of Retrograde Delivery of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Patients Diagnosed With Congestive Heart Failure (CHF)

Resource links provided by NLM:


Further study details as provided by Harvest Technologies:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    To demonstrate that the infusion of bone marrow nucleated cells into the coronary sinus is safe as assessed by adverse event records.


Secondary Outcome Measures:
  • Assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    To assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina as measured by QOL questionnaire, Minnesota Living with Heart Failure, NYHA and CCS classification and SPECT.

  • Assess the effect of the infusion of bone marrow nucleated cells on the clinical course of heart failure [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    To assess the effect of the infusion of bone marrow nucleated cells on the clinical course of heart failure as measured by QOL questionnaire, Minnesota Living with Heart Failure, NYHA and CCS classification and SPECT.


Enrollment: 30
Study Start Date: February 2011
Study Completion Date: October 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMAC Infusion
Infusion of autologous bone marrow aspirate concentrated nucleated sells into the coronary sinus
Device: BMAC infusion
Infusion of 60 mL of Bone Marrow Aspirate Concentrate
Other Name: Coronary infusion of BMAC
No Intervention: Control
Standard of care only. No infusion

Detailed Description:

To demonstrate that the infusion of bone marrow nucleated cells into the coronary sinus is safe as assessed by adverse event records.

To assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina and heart failure as measured by QOL questionnaire, Minnesota Living with Heart Failure, NYHA and CCS classification and SPECT.

To assess the effect of the infusion of bone marrow nucleated cells on heart function as measured by ejection fraction (EF) and left ventricular end-diastolic diameter (LVEDD) by ECHO.

To assess the effect of the infusion of bone marrow nucleated cells on the area of ischemia as measured by myocardial SPECT studies and ECHO.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years and ability to understand the planned treatment.
  • Patients with Congestive Heart Failure
  • Left ventricular ejection fraction ≤40% by echocardiogram, per ECHO completed 30 days prior to treatment
  • Symptomatic heart failure NYHA class III or IV
  • Able to comply with all study-related visits
  • Able to tolerate study procedures, including bone marrow aspiration, SPECT,
  • Able to give informed Consent
  • Negative for HcG with a serum pregnancy test
  • Patients with controlled diabetes mellitus (HbA1c < 9.0%)
  • Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000,
  • Life expectancy of 6 months or more in the opinion of the investigator
  • Patients requiring high dose corticosteroid therapy (more than 7.5 mg/day) with 1 month before the aspiration or 6 months after the infusion.
  • Serum bilirubin, ALT, AST ≤2.5 time the upper level of normal.
  • Controlled blood pressure (systolic blood pressure ≤140 and a diastolic blood pressure of ≤90 mmHG) and established anti-hypertensive therapy as necessary prior to entry into the study
  • Patient has received stable, standard medical therapy for at least one month with no new medications to treat the disease introduced in the last 3 months.
  • Pre-existing condition (e.g. thromboembolic risk, diabetes, hypercholesterolemia are adequately controlled in the opinion of the investigator)
  • Fertile patients (male and female) must agree to use an appropriate form of contraception while participating in the study.

Exclusion Criteria:

  • Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method, or who intend to become pregnant during the tenure of this study.
  • History of prior radiation exposure for oncological treatment.
  • History of Bone Marrow Disorder (especially NHL, MDS) that prohibit transplantation.
  • History of abnormal bleeding or clotting.
  • History of Liver Cirrhosis.
  • End stage renal disease (Creatinine ≤ 3.0 mg / dl) and/or dialysis
  • Acute Myocardial Infarction < 1 week from treatment date.
  • Active clinical infection being treated by antibiotics within one week of enrollment
  • Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
  • Unable to have 250cc bone marrow harvested.
  • History of life-threatening arrhythmias, except if an automated implantable cardioverter defibrillator (AICD) is implanted
  • Life expectancy <6 months due to concomitant illnesses
  • Known cancer and undergoing treatment; chemotherapy and/or radiotherapy
  • Patients receiving treatment with hematopoietic growth factors (e.g., EPO, G-CSF)
  • Patients who can not stop anticoagulation therapy (warfarin) 72hrs prior to bone marrow aspiration and infusion
  • Patients who can not stop anti-platelet therapy (clopidogrel) 7 days prior to bone marrow aspiration and infusion
  • History of alcohol consumption exceeding the equivalent of 2 drinks/daily (1 drink = 5oz wine, 12oz of beer, or 1.5oz hard liquor) or illicit drug use within 6 months of screening.
  • Patient who will require continuous high dose corticosteroid therapy (more than 7.5mg/day) within 1 month before aspiration or 6 months after injection procedure.
  • Body Mass Index (BMI) of 40 kg/m2 or greater
  • Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
  • In the opinion of the investigator or the sponsor, the patient is unsuitable for cellular therapy
  • Known allergy or sensitivity to contrast agents used in imaging procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299324

Locations
Germany
Rostock University Hospital
Rostock, Germany
India
Medanta the Medicity
Gurgaon, India
Peru
Dept of Cardiology, Clinicas Maison de Sante
Lima, Peru
Sponsors and Collaborators
Harvest Technologies
Investigators
Principal Investigator: Amit Patel, MD University of Utah
  More Information

No publications provided

Responsible Party: Harvest Technologies
ClinicalTrials.gov Identifier: NCT01299324     History of Changes
Other Study ID Numbers: CHF2011-1
Study First Received: January 10, 2011
Last Updated: August 18, 2014
Health Authority: India: Drugs Controller General of India

Keywords provided by Harvest Technologies:
CHF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014