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

Harvest Technologies

Status and phase

Completed

Phase 1

Conditions

Congestive Heart Failure

Treatments

Device: BMAC infusion

Study type

Interventional

Funder types

Industry

Identifiers

NCT01299324

CHF2011-1

Details and patient eligibility

About

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).

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.