Feasibility Study of BMAC Enhanced CABG

• Sponsor: Harvest Technologies (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01074099
• Collaborator: University of Utah (Other)
• Enrollment: 5
• Locations: 2
• Arms: 2
• Duration (Months): 26
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure	Biological: BMAC; Procedure: CABG only	Phase 1/Phase 2

Detailed Description

Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium. Control subjects will undergo CABG only

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Feasibility Study of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Congestive Heart Failure Patients Undergoing Treatment With Coronary Artery Bypass Grafting(CABG) Surgery
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control CABG only	Procedure: CABG only; Control subjects will undergo CABG surgery without BMAC injection
Experimental: BMAC enhanced CABG Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery	Biological: BMAC; Injection of BMAC into ischemic myocardium during CABG

Outcome Measures

Primary Outcome Measures

1. Change in Cardiac Status (Classification) [Through 12 months post treatment]

   A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation

2. Safety [through 1 Year post tx]

   as measured by frequency and severity of adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age> 18 years and ability to understand the planned treatment.

• Patients with ischemic congestive heart failure requiring by pass surgery

• Congestive heart failure with ejection fraction ≤ 40%.

• Serum bilirubin, SGOT and SGPT ≤2.5 time the upper level of normal.

• Serum creatinine < 3.0 or no dialysis.

• NYHA performance status ≥ 3.

• Negative pregnancy test (in women with childbearing potential).

• Subject has read and signed the IRB approved Informed Consent form

• Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000, Creatinine ≤ 3.0 mg / Dl, and/or no dialysis, INR ≤ 1.6 unless on Coumadin, or PTT <1.5 x control (to avoid bleeding complications) Patients on Coumadin will be corrected prior to the procedure and must have an INR<1.6 at the time of randomization/surgery

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.

• Acute Myocardial Infarction < 4 weeks from treatment date.

• Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemoccult unless follow-up studies reveal patient to be cancer free.

• Active clinical infection being treated by antibiotics within one week of enrollment

• Terminal renal failure with existing dependence on dialysis

• Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.

• Unable to have 250cc bone marrow harvested.

• Medical risk that precludes anesthesia or ASA Class 5

• History of ventricular arrhythmia if AICD is not present.

• History of ventricular aneurysm.

• Concurrent surgery such as CABG with valve surgery.

• Minimally Invasive bypass surgery

• Life expectancy <6 months due to concomitant illnesses

• Treatment with immunosuppressant drugs (including Prednisone > 5 mg per day)

• Patients undergoing urgent by pass surgical procedure

• Patients with HGB A1C > 8.5%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Methodist Hospital	Houston	Texas	United States	77030
2	University of Utah	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• Harvest Technologies
• University of Utah

Investigators

• Principal Investigator: Amit Patel, MD, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Harvest Technologies
• ClinicalTrials.gov Identifier: NCT01074099
• Other Study ID Numbers: Harvest 2009-1
• First Posted: Feb 24, 2010
• Last Update Posted: Jan 18, 2016
• Last Verified: Aug 1, 2014

• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Arm/Group Title	Control	BMAC Enhanced CABG
Arm/Group Description	CABG only CABG only: Control subjects will undergo CABG surgery without BMAC injection	Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery BMAC: Injection of BMAC into ischemic myocardium during CABG
Period Title: Overall Study
STARTED	2	3
COMPLETED	2	3
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control	BMAC Enhanced CABG	Total
Arm/Group Description	CABG only CABG only: Control subjects will undergo CABG surgery without BMAC injection	Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery BMAC: Injection of BMAC into ischemic myocardium during CABG	Total of all reporting groups
Overall Participants	2	3	5
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	3 100%	5 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	2 100%	3 100%	5 100%
Region of Enrollment (participants) [Number]
United States	2 100%	3 100%	5 100%

Outcome Measures

1. Primary Outcome

Title	Change in Cardiac Status (Classification)
Description	A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation
Time Frame	Through 12 months post treatment

Outcome Measure Data

Analysis Population Description

Study was terminated after enrollment of only 5 patients. The data were not analyzed for efficacy.

Arm/Group Title	Control	BMAC Enhanced CABG
Arm/Group Description	CABG only CABG only: Control subjects will undergo CABG surgery without BMAC injection	Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery BMAC: Injection of BMAC into ischemic myocardium during CABG
Measure Participants	0	0

2. Primary Outcome

Title	Safety
Description	as measured by frequency and severity of adverse events
Time Frame	through 1 Year post tx

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	BMAC Enhanced CABG
Arm/Group Description	CABG only CABG only: Control subjects will undergo CABG surgery without BMAC injection	Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery BMAC: Injection of BMAC into ischemic myocardium during CABG
Measure Participants	2	3
Number [participants]	0 0%	0 0%

Adverse Events

Time Frame	From time of treatment through 1 year / study termination
Arm/Group Title	Control		BMAC Enhanced CABG
Arm/Group Description	CABG only CABG only: Control subjects will undergo CABG surgery without BMAC injection		Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery BMAC: Injection of BMAC into ischemic myocardium during CABG
All Cause Mortality
	Control		BMAC Enhanced CABG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control		BMAC Enhanced CABG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		1/3 (33.3%)
Cardiac disorders
sustained ventricular tachycardia	0/2 (0%)	0	1/3 (33.3%)	1
Other (Not Including Serious) Adverse Events
	Control		BMAC Enhanced CABG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)

Limitations/Caveats

The study was terminated early. Only 5 subjects were enrolled and they were followed for a year for safety data only. One efficacy data was collected.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.