CardioCell Completes Enrollment for a Phase IIa Clinical Trial Using Its Stem Cells for Participants With Chronic Heart Failure
SAN DIEGO, CardioCell
LLC, a global biotechnology company that uses allogeneic stem cells for
cardiovascular indications, fulfills enrollment for its Phase IIa chronic heart
failure (HF) clinical trial. A total of 23 randomized participants were enrolled
at study centers at Emory University in Atlanta, MedStar
Washington Hospital Center in Washington, D.C., Northwestern Universityin Chicago, Stony Brook
University on Long Island and the University of Pennsylvania in Philadelphia. 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," aims to test if CardioCell's approach is safe and
provides evidence of improvement in participants with non-ischemic chronic HF.
"CardioCell is very encouraged by the initial results of this Phase IIa chronic heart failure trial," says Dr.Sergey Sikora, CardioCell's president and CEO. "Now that we've met our target enrollment number, we anticipate presenting preliminary results later this year and proceeding to a larger chronic heart failure study to assess clinical outcomes."
Dr. Javed Butler, a noted cardiologist who co-chairs CardioCell's Heart Failure Advisory Board and serves as CardioCell's Scientific Advisory Board Member, has been studying this condition for more than a decade and is leading the effort in designing protocols for CardioCell's chronic heart failure studies. "To test safety and preliminary efficacy, we designed this CardioCell chronic heart failure clinical trial to use this novel intervention in a very carefully selected group of patients who met rigorous inclusion and exclusion criteria," says Dr. Javed Butler, Chief of Cardiology at Stony Brook University. "We are happy to report that we met the target participant enrollment and are very carefully monitoring progress."
The Phase IIa study protocol delivers ischemia-tolerant mesenchymal stem cells (itMSCs) via intravenous infusion and investigates if the itMSCs show signs of improvement in participants with non-ischemic cardiomyopathy. More details on the study are available at:http://clinicaltrials.gov/ct2/show/NCT02123706.
Only CardioCell's chronic HF therapies feature itMSCs, which are exclusively licensed from CardioCell's parent company Stemedica. Unlike MSCs grown under normoxic conditions, Stemedica's bone-marrow-derived, allogeneic itMSCs are grown under hypoxic conditions. In vivo 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.
Source: CardioCell LLC
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