Retrograde Delivery of BMAC (Bone Marrow Aspirate Concentrate) for Congestive Heart Failure
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMAC infusion
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring CHF
Eligibility 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.
Sites / Locations
- Rostock University Hospital
- Medanta the Medicity
- Dept of Cardiology, Clinicas Maison de Sante
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
BMAC Infusion
Control
Arm Description
Infusion of autologous bone marrow aspirate concentrated nucleated sells into the coronary sinus
Standard of care only. No infusion
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01299324
Brief Title
Retrograde Delivery of BMAC (Bone Marrow Aspirate Concentrate) for Congestive Heart Failure
Official Title
Feasibility Study of Retrograde Delivery of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Patients Diagnosed With Congestive Heart Failure (CHF)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Harvest Technologies
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
CHF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMAC Infusion
Arm Type
Experimental
Arm Description
Infusion of autologous bone marrow aspirate concentrated nucleated sells into the coronary sinus
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care only. No infusion
Intervention Type
Device
Intervention Name(s)
BMAC infusion
Other Intervention Name(s)
Coronary infusion of BMAC
Intervention Description
Infusion of 60 mL of Bone Marrow Aspirate Concentrate
Primary Outcome Measure Information:
Title
Number of participants with adverse events as a measure of safety and tolerability
Description
To demonstrate that the infusion of bone marrow nucleated cells into the coronary sinus is safe as assessed by adverse event records.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Assess the effect of the infusion of bone marrow nucleated cells on the clinical course of angina
Description
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.
Time Frame
12 Months
Title
Assess the effect of the infusion of bone marrow nucleated cells on the clinical course of heart failure
Description
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.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Patel, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rostock University Hospital
City
Rostock
Country
Germany
Facility Name
Medanta the Medicity
City
Gurgaon
Country
India
Facility Name
Dept of Cardiology, Clinicas Maison de Sante
City
Lima
Country
Peru
12. IPD Sharing Statement
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Retrograde Delivery of BMAC (Bone Marrow Aspirate Concentrate) for Congestive Heart Failure
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