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First patient treated with promising bone marrow cell therapy for heart failure.

BALTIMORE, Md., February 28, 2017 -- The first patient has been treated in the pivotal Phase 3 clinical trial of an autologous cell-based therapy for the treatment of ischemic heart failure that develops after a heart attack.

The patient was treated at Johns Hopkins Hospital here.

Others involved in the trial included the Maryland Stem Cell Research Fund (MSCRF), which provided funding, and BioCardia, Inc. (BCDA), which contributed the CardiAMP therapy.

The investigational CardiAMP therapy is designed to deliver a high dose of a patient's own bone marrow cells directly to the point of cardiac dysfunction, potentially stimulating the body's natural healing mechanism after a heart attack.

The patient experience with the therapy begins with a preprocedural cell potency screening test.

If a patient qualifies for therapy, they are scheduled for a bone marrow aspiration.

A point of care cell processing platform is then utilized to concentrate the autologous bone marrow cells, which are subsequently delivered in a minimally-invasive procedure directly to the damaged regions in a patient's heart.

"This cell-based therapy offers great potential for heart failure patients," said Carl Pepine of the University of Florida, Gainesville. "We look forward to validating the impact of the therapy on patients' quality of life and functional capacity in this important study."

The CardiAMP Heart Failure Trial is a phase 3, multi-center, randomized, double-blinded, sham-controlled study of up to 260 patients at up to 40 centers nationwide, which includes an optional 10-patient roll-in cohort.

The primary endpoint for the trial is a significant improvement in Six Minute Walk distance at 12 months' post-treatment.

Study subjects must be diagnosed with New York Heart Association (NYHA) Class II or III heart failure as a result of a previous heart attack.

BioCardia, Inc., (San Carlos, Calif.) is developing regenerative biologic therapies to treat cardiovascular disease.

CardiAMP and CardiALLO cell therapies are the company's biotherapeutic product candidates in clinical development.




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Title Annotation:In The Clinic ...
Publication:Stem Cell Business News
Geographic Code:1U5MD
Date:Mar 6, 2017
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