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

NCT01299324 | Completed Phase 1 DMC

• 1 other identifier: CHF2011-1
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 3

Brief Summary

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).

Conditions

Congestive Heart Failure

Keywords

CHF

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events as a measure of safety and tolerability

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

  12 Months

Secondary Outcomes (2)

• Assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina

  12 Months

• Assess the effect of the infusion of bone marrow nucleated cells on the clinical course of heart failure

  12 Months

Study Arms (2)

BMAC Infusion

EXPERIMENTAL

Infusion of autologous bone marrow aspirate concentrated nucleated sells into the coronary sinus

Device: BMAC infusion

Control

NO INTERVENTION

Standard of care only. No infusion

Interventions

BMAC infusion DEVICE

Infusion of 60 mL of Bone Marrow Aspirate Concentrate

Also known as: Coronary infusion of BMAC

BMAC Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvest Technologies: lead

Study Sites (3)

Rostock University Hospital

Rostock, Germany

Location

Medanta the Medicity

Gūrgaon, India

Location

Dept of Cardiology, Clinicas Maison de Sante

Lima, Peru

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Amit Patel, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: February 18, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2013
• Last Updated: August 19, 2014

Record last verified: 2014-08

Locations

PE (1); DE (1); IN (1)