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FDA Approves CardioCell’s Phase 2A Trial For CHF Stem Cell Therapy

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By Estel Grace Masangkay

CardioCell LLC announced that it has received FDA approval for its investigational new drug (IND) application for a U.S.-based Phase IIA clinical study evaluating its allogeneic stem-cell therapy for patients with chronic heart failure (CHF).

Dr. Sergey Sikora, CardioCells president and CEO, said, With the FDAs IND approval, CardioCell is pleased to proceed with a Phase 2a CHF clinical trial based on the safety data reported in previous clinical trials using our unique, hypoxically grown stem cells. At the studys conclusion we will understand if our therapy produces signs of improvement in a population of patients with dilated CHF, a condition largely unaddressed by current therapies. Dilated CHF is characterized by a viable but non-functioning myocardium in which cardiomyocytes are alive but are not contracting as they should. We hope that unique properties of our itMSCs will transition patients cardiomyocytes from viable to functioning, eventually improving or restoring heart function.

The company has developed an ischemic tolerant mesenchymal stem cells (itMSC) treatment for the type of dilated CHF that is not related to coronary artery disease. The treatment could potentially apply to about 35 percent of CHF patients. Only CardioCells CHF therapies feature itMSCs, exclusively licensed from CardioCells parent company Stemedica Cell Technologies Inc. The company said Stemedicas bone marrow-derived, allogeneic MSCs are different from other MSCs because they are grown under hypoxic conditions that closely resemble the environment in which they thrive on in the body.

Dr. Stephen Epstein, CardioCells Scientific Advisory Board Chair, said Although past trials have tested the efficacy of different stem cells in patients with DCM, CardioCells itMSCs, grown under chronic hypoxic conditions, are unique. As compared to stem cells grown under normoxic conditions, they express higher levels of factors that could exert beneficial effects on the mechanisms contributing to myocardial dysfunction and disease progression. This study, therefore, provides an exciting opportunity to test the potential of these itMSCs to attenuate or eliminate these mechanisms and, in so doing, improve patient outcomes.

The trial entitled A Phase 2a, Single-Blind, Placebo-Controlled, Crossover, Multi-Center, Randomized Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-Tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Heart Failure of Non-Ischemic Etiology, will be conducted at Emory University, Northwestern University, and the University of Pennsylvania in May this year.

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FDA Approves CardioCell's Phase 2A Trial For CHF Stem Cell Therapy

Facebook Data Science Team Announces Open Source Tools for A/B Testing

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Facebook is continuing their mission of donating goodness to the community with the release of sourcr code called PlanOut. PlanOut is used for online A/B testing experiments.

This is a great move for Facebook, developers, and the data community. As we talk about on SiliconANGLE Wikibon and theCUBE is that Data science is the hottest emerging trend that is creating new value that has never been seen before.

This is a great preview of the upcoming F8 conference on April 30th in SF.

When people think about the tools of data science, they often focus on machine learning, statistics, and data manipulation. Modeling massive datasets is indispensable for making predictions like predicting which set of News Feed stories or search results are most relevant to people. But such models also have limitations in terms of their ability to help with understanding cause-and-effect relationships that lead to building better products and to advancing behavioral science.

Data science needs better tools for running experiments

Despite the abundance of experimental practices in the Internet industry, there are few tools or standard practices for running online field experiments. And existing tools tend to focus on rolling out new features, or automatically optimizing some outcome of interest.

At Facebook, we run over a thousand experiments each day. While many of these experiments are designed to optimize specific outcomes, others aim to inform long-term design decisions. And because we run so many experiments, we need reliable ways of routinizing experimentation. As Ronald Fisher, a pioneer in statistics and experimental design said, To consult the statistician after an experiment is finished is often merely to ask him to conduct a post-mortem examination. He can perhaps say what the experiment died of. Many online experiments are implemented by engineers who are not trained statisticians. While experiments are often simple to analyze when done correctly, it can be surprisingly easy to make mistakes in their design, implementation, logging, and analysis. One way to consult a statistician in advance is to have their advice built into tools for running experiments

PlanOut: a framework for running online field experiments

Good tools not only enable good practices, they encourage them. Thats why we created PlanOut, a set of tools for running online field experiments, and are sharing an open source version of it as part of the Data Science Teams first software release.

Importantly, PlanOut gives engineers and scientists a language for defining random assignment procedures. Experiments, ranging from simple A/B tests, to factorial designs that decompose large interface changes, to more complex within-subjects designs, can be expressed with only a few lines of code. In this way, PlanOut encourages running experiments that are more akin to the kind you see in the behavioral sciences.

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Facebook Data Science Team Announces Open Source Tools for A/B Testing