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Patents Awarded for Stem Cell Heart Disease Technologies

U.S. Patent and Trademark Office

U.S. Patent and Trademark Office (A. Kotok)

14 September 2018. A company developing treatments for heart disease using stem cells to regenerate healthy heart tissue received two new patents for techniques supporting its core processes. The U.S. Patent and Trademark Office granted patent number 10,035,982 on 31 July and 10,071,226 on 11 September to Peter Altman, president and CEO of BioCardia Inc. in San Carlos, California and other inventors.

BioCardia produces therapies for heart failure and other cardiac disorders with stem cells derived from bone marrow. Heart failure is a condition where the heart cannot pump enough blood to meet the body’s needs, a condition affecting some 5.7 million people in the U.S., according to Centers for Disease Control and Prevention. Most cases of heart failure affect both the left and right sides of the heart, although in some cases only one side is affected. The leading causes of heart failure are conditions that weaken or damage the heart, including coronary heart disease, high blood pressure, and diabetes.

The company is developing two types of therapies, the CardiAmp system for harvesting a patient’s own stem cells to regenerate new heart tissue, and the CardiAllo system that uses donated stem cells, when a person’s own bone marrow may not support the CardiAmp system. CardiAmp treatments are administered in a same-day procedure that the company says takes 60 to 90 minutes, beginning with a diagnostic test to confirm the patient’s bone marrow will support the process.

The CardiAmp process takes a sample of the patient’s bone marrow from the hip, where stem cells and heart progenitor cells are extracted and reprogrammed at bed side into dosage quantities. The reprogrammed stem cells are then delivered to the heart through the company’s Helix catheter system. As reported by Science & Enterprise in December 2016, BioCardia is testing the CardiAmp system in late-stage clinical trials.

The CardiAllo system uses donated bone marrow stem cells, frozen and transported to the transplant hospital site. The cells are then thawed, processed, and delivered with a Helix catheter. The company says CardiAllo patients can be discharged the same day as the treatments or kept overnight.

The 31 July patent describes a process for expanding an individual’s own bone marrow stem cells, as used in the CardiAmp system. The document covers different steps in the process performed in a clinical setting. The text includes the culture medium for expanding the stem cells, and a diagnostic test to look for expression of specific genes in the bone marrow cells indicating a person’s ability to support the procedure.

The 11 September patent covers a new catheter for delivering CardiAmp and CardiAllo treatments through the radial artery in the patient’s forearm. The document covers the technology for guiding a needle through the radial artery, which the text says is a better method for reaching the heart chamber than the femoral artery in the groin, the usual route including the company’s current catheter. The radial artery, says the patent text, is safer and more economical, allowing for the company’s stem cell treatments to be given in an outpatient setting.

BioCardia says it plans to include the new catheter in its CardiAmp and CadiAllo treatments. In a company statement, Altman adds, “Based on the positive early data from our ongoing pivotal CardiAmp heart failure trial and previous data sets, we at BioCardia are optimistic that we may be the first to have an approved cardiac cell therapy in the United States.”

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