The American Heart Journal has published one year follow-up on a clinical investigation of a noninvasive catheter-based therapy for delivering a patient’s own adult stem cells to the heart.
June 28, 2007 (Press Release) --
The study entitled, “Transendocardial autologous bone marrow in chronic myocardial infarction using a helical needle catheter: 1-year follow-up in an open-label, nonrandomized, single-center pilot study (the TABMMI study)” was intended as an open label safety trial and was based on significant preclinical data. The study was led by Dr. Luis de la Fuente and Dr. Simon Stertzer among leading interventional cardiologists at the Argentine Institute for Diagnosis and Treatment, the Swiss Clinic, and Stanford University Medical Center.
The TABMMI study involves using a needle to withdraw a small volume of bone marrow from the hip bone of a patient in the morning. While the patient is resting, their marrow derived stem cells are isolated, washed, and counted. Later the same day, the patients enter a cardiac catheterization suite for noninvasive delivery of their own bone marrow stem cells to the heart. Cells are delivered through a catheter system that is threaded into the heart chamber from an opening in a blood vessel in the leg. Within the heart, a small helical needle is advanced into the myocardium to deliver cells to a number of different locations over a period of ten to twenty minutes. This “transendocardial” approach, developed by BioCardia, enables physicians to target and deliver to any site in the heart, including those that have poor blood flow.
BioCardia’s CEO, Dr. Peter Altman states, “The BioCardia Helix catheter system should improve ease of delivery, improve retention, reduce likelihood of perforation when compared to other catheter systems. That it has been shown to be safe in this population that suffers from chronic cardiovascular disease is a significant milestone. ”
The principle investigator for the trial, Dr. de la Fuente, described the results as “remarkable, in that all patients showed evidence of functional improvement at both six months and one year follow-up. Patients are rapidly approaching two year follow-up and reported as doing well. “
About BioCardia
Formed in 1999, BioCardia, Inc. is a leader in the development of catheter systems which enable local delivery of therapeutics to the heart and other organs. BioCardia currently is marketing the BioCardia Morph™ Deflectable Tip Guide Catheter. Biotherapeutic clinical trials are ongoing using BioCardia’s Helical Infusion System to deliver cell, gene, and protein therapies directly to the heart muscle.
The TABMMI study involves using a needle to withdraw a small volume of bone marrow from the hip bone of a patient in the morning. While the patient is resting, their marrow derived stem cells are isolated, washed, and counted. Later the same day, the patients enter a cardiac catheterization suite for noninvasive delivery of their own bone marrow stem cells to the heart. Cells are delivered through a catheter system that is threaded into the heart chamber from an opening in a blood vessel in the leg. Within the heart, a small helical needle is advanced into the myocardium to deliver cells to a number of different locations over a period of ten to twenty minutes. This “transendocardial” approach, developed by BioCardia, enables physicians to target and deliver to any site in the heart, including those that have poor blood flow.
BioCardia’s CEO, Dr. Peter Altman states, “The BioCardia Helix catheter system should improve ease of delivery, improve retention, reduce likelihood of perforation when compared to other catheter systems. That it has been shown to be safe in this population that suffers from chronic cardiovascular disease is a significant milestone. ”
The principle investigator for the trial, Dr. de la Fuente, described the results as “remarkable, in that all patients showed evidence of functional improvement at both six months and one year follow-up. Patients are rapidly approaching two year follow-up and reported as doing well. “
About BioCardia
Formed in 1999, BioCardia, Inc. is a leader in the development of catheter systems which enable local delivery of therapeutics to the heart and other organs. BioCardia currently is marketing the BioCardia Morph™ Deflectable Tip Guide Catheter. Biotherapeutic clinical trials are ongoing using BioCardia’s Helical Infusion System to deliver cell, gene, and protein therapies directly to the heart muscle.
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