Stem Cell Therapy in Patients With Severe Heart Failure & Undergoing Left Ventricular Assist Device Placement

NCT00869024 | Completed Phase 1 Results DMC

• 1 other identifier: 1106M00401
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the delivery of cells just after implantation of left ventricular assist device will help to improve the pumping function of your heart and minimize heart enlargement in the future. The cells will be obtained by aspiration or withdrawal of fluid from your bone marrow from your pelvic bone using a needle and syringe. This would not take place until 24-48 hours prior to your planned left ventricular assist device implantation. During the surgery the surgeons will inject the prepared cells that were taken from your bone marrow and inject it into your heart muscle. This study will test whether receiving your own bone marrow cells directly into your heart will help your heart to recover function after placement of a left ventricular assist device.

Conditions

Heart Failure

Keywords

Heart failure; Left ventricular assist device; Stem cells

Outcome Measures

Primary Outcomes (3)

• Safety of Cell Delivery

  Safety as measured by the total number of adverse events per group.

  24 months

• Improvement in Myocardial Viability by PET/CT Scan

  Change in LAD segments from baseline to 10 weeks. PET scan viability is reported by segment on a scale of 0-4. A score of 0, 1, or 2 are categorized as viable/healthy heart tissue and a score of 3 or 4 are categorized as not viable/scar tissue. No change or better in viability will be reported to determine safety of cell injection. Measurement is reported as number of segment that remained the same or improved were considered "safe" for stem cell injection.

  baseline, 10 weeks

• Combined End Points of Death

  Number of participants who expired during the study.

  24 months

Secondary Outcomes (3)

• Number of Participants Turned Down Without Meeting LVAD Stopping Rules

  10 weeks

• Change in Left Ventricular Dimensions

  10 weeks

• Histological Assessment

  24 months

Study Arms (2)

Stem Cell therapy

EXPERIMENTAL

Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells in Patients with Severe LV Dysfunction and LVAD Support

Biological: Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells

Placebo

PLACEBO COMPARATOR

Intramyocardial Delivery Placebo solution into Patients with Severe LV Dysfunction and LVAD Support

Biological: Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells

Interventions

Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells BIOLOGICAL

Ten separate injections will be delivered into the LV free wall (20 X 106 cells / 400 micro lit).

Placebo; Stem Cell therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe LV dysfunction with EF \< 30% with cardiomyopathy ( Ischemic and non ischemic)
• NYHA Class III and IV
• No revascularization options available
• LVAD placement as destination therapy or bridging to transplantation
• Age between 18-80 years

You may not qualify if:

• History of recent malignancy( less than one year) .
• Unstable hemodynamics at the time of the implant; defined by need for increasing vasopressor medication in the last 24 hours or blood pressure \< 70 systolic, or cardiac index \< 1.3 liters/min.
• Coronary anatomy suitable for revascularization at the time of surgery
• Pregnancy confirmed by positive urine test
• Lactating mothers
• Renal failure with serum creatinine \>3.0, or are receiving chronic dialysis support.
• Inability to undergo PET/CT imaging.
• A history of any significant recent bleeding disorder or coagulation profile of concern for acute bleeding, such as INR \>2.0 (not on anticoagulant), platelet count \<100,000, or hemoglobin \<8.0 gr/dl.
• Patients with known infectious disease (Hepatitis, HIV) etc.
• Patients with three times or more of the upper limits of normal enzymes.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University Of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Ganesh Raveendran
• Organization: University of Minnesota

ravee001@umn.edu

612-626-4283

Study Officials

• Ganesh Raveendran, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: November 10, 2011
• Primary Completion: March 29, 2016
• Study Completion: March 29, 2016
• Last Updated: March 13, 2020
• Results First Posted: March 13, 2020

Record last verified: 2020-02

Locations

US (1)