title: Safety and efficacy of ixmyelocel-T: an expanded, autologous multi-cellular therapy, in dilated cardiomyopathy.
abstract: BACKGROUND
  Ixmyelocel-T is associated with a wide range of biological activities relevant to tissue repair and regeneration.
  
  
  OBJECTIVE
  To evaluate the safety and efficacy of ixmyelocel-T in 2 prospective randomized phase 2A Trials administered via minithoracotomy or intramyocardial catheter injections in patients with dilated cardiomyopathy (DCM) stratified by ischemic or nonischemic status.
  
  
  RESULTS
  In IMPACT-DCM, patients were randomized to either ixmyelocel-T or standard-of-care control in a 3:1 ratio (n=39); ixmyelocel-T was administered intramyocardially via minithoracotomy. In Catheter-DCM, patients were randomized to either ixmyelocel-T or standard of care control in a 2:1 ratio (n=22); ixmyelocel-T was administered intramyocardially using the NOGA Myostar catheter. Only patients randomized to ixmyelocel-T underwent bone marrow aspiration and injections. In the 2 studies, a total of 61 patients were randomized, and 59 were treated or received standard of care. Fewer ischemic patients treated with ixmyelocel-T experienced a major adverse cardiovascular event during follow-up when compared with control patients. A similar benefit was not seen in the nonischemic patients. Heart failure exacerbation was the most common major adverse cardiovascular event. Ixmyelocel-T treatment was associated with improved New York Heart Association class, 6-minute walk distance, and Minnesota Living with Heart Failure Questionnaire scores in the ischemic population relative to control; a similar trend was not observed in the nonischemic population.
  
  
  CONCLUSIONS
  Intramyocardial injection with ixmyelocel-T reduces major adverse cardiovascular event and improves symptoms in patients with ischemic DCM but not in patients with nonischemic DCM.
authors.affiliation: From the Division of Cardiology, Cedars-Sinai Medical Center, The Heart Institute, Los Angeles, CA (T.D.H.); Division of Cardiology (T.D.H.) and Cardiovascular Division (J.H.T.), Minneapolis Heart Institute Foundation, MN; Division of Cardiothoracic Surgery (B.L.H.) and Clinical Cardiovascular Research Center (C.A.E.), Soltero Cardiovascular Research Center, Baylor University Medical Center, Dallas, TX; Division of Cardiovascular Surgery, DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, TX (B.B.); Division of Cardiothoracic Surgery, University of Utah School of Medicine, Salt Lake City (D.A.B., A.N.P.); and Aastrom Biosciences, Inc, Ann Arbor, MI (A.E.R., D.R.). henryt@cshs.org.
authors.forename: Timothy D
authors.initials: TD
authors.lastname: Henry
authors.affiliation: From the Division of Cardiology, Cedars-Sinai Medical Center, The Heart Institute, Los Angeles, CA (T.D.H.); Division of Cardiology (T.D.H.) and Cardiovascular Division (J.H.T.), Minneapolis Heart Institute Foundation, MN; Division of Cardiothoracic Surgery (B.L.H.) and Clinical Cardiovascular Research Center (C.A.E.), Soltero Cardiovascular Research Center, Baylor University Medical Center, Dallas, TX; Division of Cardiovascular Surgery, DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, TX (B.B.); Division of Cardiothoracic Surgery, University of Utah School of Medicine, Salt Lake City (D.A.B., A.N.P.); and Aastrom Biosciences, Inc, Ann Arbor, MI (A.E.R., D.R.).
authors.forename: Jay H
authors.initials: JH
authors.lastname: Traverse
authors.affiliation: From the Division of Cardiology, Cedars-Sinai Medical Center, The Heart Institute, Los Angeles, CA (T.D.H.); Division of Cardiology (T.D.H.) and Cardiovascular Division (J.H.T.), Minneapolis Heart Institute Foundation, MN; Division of Cardiothoracic Surgery (B.L.H.) and Clinical Cardiovascular Research Center (C.A.E.), Soltero Cardiovascular Research Center, Baylor University Medical Center, Dallas, TX; Division of Cardiovascular Surgery, DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, TX (B.B.); Division of Cardiothoracic Surgery, University of Utah School of Medicine, Salt Lake City (D.A.B., A.N.P.); and Aastrom Biosciences, Inc, Ann Arbor, MI (A.E.R., D.R.).
authors.forename: Baron L
authors.initials: BL
authors.lastname: Hammon
authors.affiliation: From the Division of Cardiology, Cedars-Sinai Medical Center, The Heart Institute, Los Angeles, CA (T.D.H.); Division of Cardiology (T.D.H.) and Cardiovascular Division (J.H.T.), Minneapolis Heart Institute Foundation, MN; Division of Cardiothoracic Surgery (B.L.H.) and Clinical Cardiovascular Research Center (C.A.E.), Soltero Cardiovascular Research Center, Baylor University Medical Center, Dallas, TX; Division of Cardiovascular Surgery, DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, TX (B.B.); Division of Cardiothoracic Surgery, University of Utah School of Medicine, Salt Lake City (D.A.B., A.N.P.); and Aastrom Biosciences, Inc, Ann Arbor, MI (A.E.R., D.R.).
authors.forename: Cara A
authors.initials: CA
authors.lastname: East
authors.affiliation: From the Division of Cardiology, Cedars-Sinai Medical Center, The Heart Institute, Los Angeles, CA (T.D.H.); Division of Cardiology (T.D.H.) and Cardiovascular Division (J.H.T.), Minneapolis Heart Institute Foundation, MN; Division of Cardiothoracic Surgery (B.L.H.) and Clinical Cardiovascular Research Center (C.A.E.), Soltero Cardiovascular Research Center, Baylor University Medical Center, Dallas, TX; Division of Cardiovascular Surgery, DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, TX (B.B.); Division of Cardiothoracic Surgery, University of Utah School of Medicine, Salt Lake City (D.A.B., A.N.P.); and Aastrom Biosciences, Inc, Ann Arbor, MI (A.E.R., D.R.).
authors.forename: Brian
authors.initials: B
authors.lastname: Bruckner
authors.affiliation: From the Division of Cardiology, Cedars-Sinai Medical Center, The Heart Institute, Los Angeles, CA (T.D.H.); Division of Cardiology (T.D.H.) and Cardiovascular Division (J.H.T.), Minneapolis Heart Institute Foundation, MN; Division of Cardiothoracic Surgery (B.L.H.) and Clinical Cardiovascular Research Center (C.A.E.), Soltero Cardiovascular Research Center, Baylor University Medical Center, Dallas, TX; Division of Cardiovascular Surgery, DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, TX (B.B.); Division of Cardiothoracic Surgery, University of Utah School of Medicine, Salt Lake City (D.A.B., A.N.P.); and Aastrom Biosciences, Inc, Ann Arbor, MI (A.E.R., D.R.).
authors.forename: Ann E
authors.initials: AE
authors.lastname: Remmers
authors.affiliation: From the Division of Cardiology, Cedars-Sinai Medical Center, The Heart Institute, Los Angeles, CA (T.D.H.); Division of Cardiology (T.D.H.) and Cardiovascular Division (J.H.T.), Minneapolis Heart Institute Foundation, MN; Division of Cardiothoracic Surgery (B.L.H.) and Clinical Cardiovascular Research Center (C.A.E.), Soltero Cardiovascular Research Center, Baylor University Medical Center, Dallas, TX; Division of Cardiovascular Surgery, DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, TX (B.B.); Division of Cardiothoracic Surgery, University of Utah School of Medicine, Salt Lake City (D.A.B., A.N.P.); and Aastrom Biosciences, Inc, Ann Arbor, MI (A.E.R., D.R.).
authors.forename: David
authors.initials: D
authors.lastname: Recker
authors.affiliation: From the Division of Cardiology, Cedars-Sinai Medical Center, The Heart Institute, Los Angeles, CA (T.D.H.); Division of Cardiology (T.D.H.) and Cardiovascular Division (J.H.T.), Minneapolis Heart Institute Foundation, MN; Division of Cardiothoracic Surgery (B.L.H.) and Clinical Cardiovascular Research Center (C.A.E.), Soltero Cardiovascular Research Center, Baylor University Medical Center, Dallas, TX; Division of Cardiovascular Surgery, DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, TX (B.B.); Division of Cardiothoracic Surgery, University of Utah School of Medicine, Salt Lake City (D.A.B., A.N.P.); and Aastrom Biosciences, Inc, Ann Arbor, MI (A.E.R., D.R.).
authors.forename: David A
authors.initials: DA
authors.lastname: Bull
authors.affiliation: From the Division of Cardiology, Cedars-Sinai Medical Center, The Heart Institute, Los Angeles, CA (T.D.H.); Division of Cardiology (T.D.H.) and Cardiovascular Division (J.H.T.), Minneapolis Heart Institute Foundation, MN; Division of Cardiothoracic Surgery (B.L.H.) and Clinical Cardiovascular Research Center (C.A.E.), Soltero Cardiovascular Research Center, Baylor University Medical Center, Dallas, TX; Division of Cardiovascular Surgery, DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, TX (B.B.); Division of Cardiothoracic Surgery, University of Utah School of Medicine, Salt Lake City (D.A.B., A.N.P.); and Aastrom Biosciences, Inc, Ann Arbor, MI (A.E.R., D.R.).
authors.forename: Amit N
authors.initials: AN
authors.lastname: Patel
mesh_terms: D000368:Aged; D002311:Cardiomyopathy, Dilated / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D057785:Catheters; D017690:Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D064987:Cell- and Tissue-Based Therapy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006334:Heart Function Tests; D006801:Humans; D007511:Ischemia / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009206:Myocardium / Q000473:pathology; D011446:Prospective Studies; D015899:Tomography, Emission-Computed, Single-Photon; D014182:Transplantation, Autologous; D016896:Treatment Outcome
keywords: cardiomyopathy, dilated; clinical trial; heart failure; stem cell