CardioCell Expands Chronic Heart Failure Phase IIa Clinical Trial

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CardioCell Expands Chronic Heart Failure Phase IIa Clinical Trial to MedStar Washington Hospital Center

March 24, 2016 By Cade Hildreth (CEO)

In news released today, CardioCell, LLC, announced that a fifth treatment center has been chosen for participation in its Phase II clinical trial that will investigate the use of allogeneic mesenchymal bone marrow cells (aMBMC) in the treatment of non-ischemic heart failure (Study #NCT02467387). Now recruiting patients for this fifth location, the clinical study launched June 2014 and has an estimated end date of April 2017.

To learn more about the announcement, see the full press release below, printed with permission from Marcie Frank, Stemedica’s Vice President, Investor Relations.

Fifth Treatment Center for CardioCell’s Chronic Heart Failure Clinical Trial Using Ischemia-Tolerant Mesenchymal Stem Cells (itMSCs) Accepts Participants

Stemedica Cell Technologies, Inc. WASHINGTON, D.C — March 22, 2016 — CardioCell LLC, a Stemedica Cell Technologies Inc. subsidiary that uses allogeneic stem cells for cardiovascular indications, welcomes MedStar Washington Hospital Center as the newest site for its Phase IIa chronic heart failure (HF) clinical trial. Participant recruitment is underway at this and four other research centers, including Emory University in Atlanta, Northwestern University in Chicago, Stony Brook University on Long Island and the University of Pennsylvania in Philadelphia.

More details on the study, entitled “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,” is available at: http://clinicaltrials.gov/ct2/show/NCT02123706.

“CardioCell is expanding its heart failure study sites in anticipation of the Phase IIb study recently recommended by our Heart Failure Advisory Board,” says Dr. Sergey Sikora, CardioCell’s president and CEO. “MedStar Washington Hospital is the perfect new location for us based on its stellar reputation for cardiology research, and we are pleased to bring this new study site online this month.”

CardioCell’s participant enrollment for the current Phase IIa chronic HF study is nearly complete. Those in the Washington, D.C., area who wish to be considered for the study can contact Praveena Machineni, clinical research coordinator at MedStar Health Research Institute, by phone at 202-877-9328 or email at Praveena.Machineni@medstar.net.

“MedStar Washington Hospital is at the forefront of heart failure research, and we are pleased to begin recruiting for CardioCell’s Phase IIa study,” says Dr. David Majure, M.D., MPH, MedStar Heart and Vascular Institute cardiologist and principal investigator for CardioCell’s Washington, D.C., study site. “We are committed to finding new ways to improve patient outcomes, and we think this CardioCell study is an important step in that journey.”

Only CardioCell’s chronic HF therapies feature itMSCs, which are exclusively licensed from CardioCell’s parent company Stemedica. Unlike all other MSCs – which are grown under normoxic conditions – Stemedica’s bone-marrow-derived, allogeneic itMSCs are unique because they are grown under hypoxic conditions. In vitro experiments demonstrate cells that are exposed to hypoxic conditions show greater homing and engraftment than cells grown under normoxic conditions. Compared to MSCs manufactured under normal oxygen condition, itMSCs secrete higher levels of growth factors and other important proteins associated with neoangiogenesis and healing.
 
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