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Patent
Capricor | Date: 2014-11-26

Medical systems and methods for treating kidney disease alone, heart failure alone, chronic kidney disease with concomitant heart failure, or cardiorenal syndrome are described. The systems and methods are based on delivery of a natriuretic peptide such as Vessel Dilator to a subject. Methods for increasing and maintaining peptide levels at a certain concentration include direct peptide delivery via either an external or implantable programmable pump.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 794.43K | Year: 2011

DESCRIPTION (provided by applicant): It was recently discovered that the adult human heart contains small numbers of resident cardiac stem cells. These stem cells are incapable of mounting a full-scale repair of the heart following a heart attack (or myocardial infarction). However, when cultivated in the lab and delivered to animals after a myocardial infarction, these cells can initiate repair processes, form new heart muscle and new vessels. Capricor, Inc. has a method to cultivate resident cardiac stemcells which is known as the cardiosphere method. Cardiospheres can be generated starting with only a small cardiac biopsy that can be obtained during an outpatient procedure. The cardiosphere method is being developed for commercialization as an autologoustreatment for cardiovascular disease in general. This project aims to make the cardiosphere method faster, cheaper, and simpler. Cell culture techniques will be modified and product equivalence demonstrated by flow cytometry.es will be applied to determine the efficacy of each cell product. This project will also explore the feasibility of product banking, such that a patient could preserve stem cells for a future application. Cells will be subjected to a controlled-rate freeze followed by a thaw process after a period of banking in liquid nitrogen. Measures of viability and potency will be made to identify any detrimental effects. Finally, with a focus on future clinical trials, we will develop assays that will allow us to predict the potency, or efficacy,of a particular patient's sample. Another series of animal studies will be conducted to measure potency in the setting of myocardial infarction, while a series of simple lab potency assays will be developed in parallel as candidate predictors. Cardiosphere-derived stem cells are already being moved toward a Phase I/II clinical safety trial. The specific aims of this project will move Capricor toward its goal of preparing for a Phase II/III clinical efo provide a possible cure for the disease or halt its progression, and to improve the health of the Nation.


The present disclosure relates generally to methods for the increased processing of tissue for the generation of cardiac stem cells, wherein the stem cells are suitable for use in cardiac stem cell therapy. In particular, several embodiments relate to the processing of allogeneic donor cardiac tissue for the generation of multiple patient doses of cardiac stem cells.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase I | Award Amount: 1.68M | Year: 2016

DESCRIPTION provided by applicant One of the most complex forms of congenital heart disease hypoplastic left heart syndrome HLHS affects an average of in every newborns with a mortality rate of up to percent during the first year of life The overall goal f our research is to develop safe and effective ways to improve short term and long term survival rates in babies born with HLHS We aim to introduce a novel cell based therapeutic strategy in the three stage surgical procedure that HLHS patients typically undergo Our hypothesis is that injected allogeneic cardiosphere derived cells CDCs will boost and regenerate the myocardium of the single right ventricle in HLHS patients improving right ventricular function and thus short and long term clinical outcomes The aims of this Phase I clinical trials are to evaluate the feasibility and safety of direct intra coronary injection of allogeneic CDCs in these HLHS patients at the time of cauterization for their second operation This proposal will translate a series of basic and pre clinical observations into a potentially paradigm shifting therapy to meet an unmet medical need in HLHS patients In addition this study will bring a deeper insight into the biology of stem cells in human patients which have never been studied before in pediatric congenital heart patients PUBLIC HEALTH RELEVANCE Hypoplastic left heart syndrome is one of the most complex forms of congenital heart disease with a reported incidence of of children born with congenital heart disease Despite these strides in medical care during the last twenty years the mortality rate of these infants remain at during the first year of life because mostly of right ventricle dysfunction This proposal will translate a series of basic and pre clinical observations into a potentially paradigm shifting cell based therapy to improve the right ventricular function and thus improve clinical outcomes


Medical systems and methods for treating kidney disease alone, heart failure alone, kidney disease with concomitant heart failure, or cardiorenal syndrome are described. The systems and methods are based on delivery of a chimeric natriuretic peptide to a patient. Methods for increasing peptide levels include direct peptide delivery via either an external or implantable programmable pump.


Patent
Capricor | Date: 2015-12-03

The invention encompasses methods for generating stable exosome formulations and encompasses stable exosome formulations. The exosome formulations encompass stable liquid exosome formulations and stable lyophilized exosome formulations. In some embodiments, the exosome formulations can be generated by ultrafiltration and diafiltration. The exosome formulations can be suitable for administration to a human.


The invention encompasses methods for generating exosomes comprising culturing cells in less than 20% oxygen for at least 2 days and harvesting exosomes from the cells. The invention further encompasses exosome preparations generated from cells cultured in less than 20% oxygen for at least 2 days.


Methods of treating heart failure, or decreasing blood pressure, comprising administering an NP at an appropriate does, or in an amount sufficient to provide particular concentrations of NP, are provided.


Therapeutic compositions containing chimeric natriuretic peptides for treating chronic kidney disease alone, heart failure alone, or chronic kidney disease with concomitant heart failure are described. The therapeutic compositions have enhanced stability characteristics to facilitate storage and delivery by provisioning apparatuses under conditions of elevated temperature and mechanical stress. Methods for increasing the stability of therapeutic compositions containing chimeric natriuretic peptides are further described.


News Article | February 23, 2017
Site: www.prnewswire.com

LOS ANGELES, Feb. 23, 2017 /PRNewswire/ -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company developing biological therapies for cardiac and other medical conditions, today announced that Linda Marbán, Ph.D, president and chief executive officer, is scheduled to present...

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