CardioCell, a San Diego stem cell company, has started a Phase 2a trial of its treatment for chronic heart failure.
The company's special stem cells will be injected into patients with heart failure not caused by a heart attack. (*Difference Between Heart Failure and Heart Attack) Nearly 2 million Americans have that kind of heart failure.
CardioCell is also testing these stem cells on heart attack patients to help their recovery. The cells are licensed from Stemedica, CardioCell's parent company.
Taken from bone marrow, the stem cells produce chemicals intended to heal malfunctioning heart cells. They are grown under low oxygen conditions, or hypoxia. CardioCell says hypoxia reflects the conditions under which natural stem cells exist. Histogen, also of San Diego, is developing its own kind of low-oxygen stem cells.
Growing stem cells with abundant oxygen reduces their "stemness," and they become prone to differentiate, said Sergey Sikora, CardioCell's president and chief executive.
More than 20 patients are being sought to take part in the study, which is taking place at three locations. These are Emory University in Atlanta, Northwestern University in Chicago, and the University of Pennsylvania in Philadelphia.
Patients will receive injections of the stem cells, and a control group will receive a saline injection. After 90 days, the groups will be reversed. Patients who had received the stem cells will get a saline injection, and the control group will get the stem cells.
The stem cells last for about a month, after which they disappear, Sikora said.
More information on the CardioCell trials is available on CardioCell's web site.
The clinical trial process usually consists of three main phases. Phase 1 trials concentrate on assessing safety, although evidence of efficacy is sometimes detected. Phase 2 marks the midpoint of the clinical trial process, which test for safety and efficacy.
Phase 2 trials continue safety testing, but include specific goals or endpoints to determine efficacy. In the case of heart failure, caused by inadequate blood-pumping ability, efficacy means an increased ability to contract and pump blood. Phase 3 trials typically includes a larger number of patients, to give more precise measurements of safety and efficacy.
After completing the stages, regulators may approve the treatment, reject it, or ask for more studies to be completed. Regulators may also ask for Phase 4 monitoring even after a drug is approved, to determine its effects in patient groups, and any long-range side effects.