Florida card questioned on patient death after stem cell treatment

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon
Stem Cell Therapy, research, pharma - 11.52 Kb

Florida cardiologist Zannos G. Grekos, MD, is under legal scrutiny due to his patient's death after receiving a stem cell treatment. Investigators are looking into whether the stem cell treatment played a role in the patient’s death and the Florida Department of Health also is questioning whether the patient signed off on the investigative treatment.

In 2006, Grekos treated a 69-year old breast cancer patient who underwent six rounds of chemotherapy and radiation followed by Arimidex, a treatment for post-menopausal women with hormone receptor-positive early stage breast cancer. Post-treatment, the patient complained of damage to her peripheral nervous system.

On Feb. 17, 2010, the patient inquired about possible stem cell treatment to treat the chemotherapy-induced neuropathy. An imaging exam, obtained Feb. 25, 2010, showed a 0 to 29 percent bilateral stenosis in the patient’s carotid arteries and a cerebral angiogram was performed on March 24, 2010. A complaint filed in August 2011 by the Florida Department of Health alleges that Grekos performed an experimental stem cell procedure on the patient by injecting autologous bone-marrow aspirate during the cerebral angiogram procedure.

Investigators allege that the stem cell treatment provided was not authorized by the FDA, and was unjustified. Additionally, lawyers say that the patient’s medical records did not contain information about the stem cell operation.

“Dr. Grekos' treatment of [the patient’s] neuropathy by the injection of autologous bone marrow aspirate into the cerebellar circulation had no substantiated medical and/or scientific value,” according to the report. The patient later died from severe brain stem infarcts of the cerebellum.

The complaint alleges that Grekos failed to practice medicine accordingly and violated Section 458.331(1)(t) of Florida Statutes by:

  • Failing to show appropriate medical records that justified the treatment for injecting autologous bone marrow aspirate into the patient’s cerebral circulation for the treatment of neuropathy;
  • Performing a procedure that had no medical or scientific value for the treatment of the patient’s neuropathy;
  • Performing a procedure that had no proper medical foundation for success;
  • Performing a procedure that was “entirely experimental and not an accepted or proven treatment” in Florida;
  • Performing a “dangerous and unwarranted” procedure and one that was “medically unnecessary;” and
  • Performing a procedure that put the patient at an inordinate risk of death and/or injury.

The filings also allege that Grekos failed to inform the patient of the risk and benefits and alternatives of the proposed stem cell treatment. Additionally, Grekos allegedly failed to make it known that the procedure was entirely experimental and unaccepted in the state of Florida.

Currently, Grekos’ license is restricted by emergency order of the department. Under the restricted license, Grekos is prohibited from providing stem cell treatment that includes injection of autologous bone marrow aspirate.

Naples News reported that the deceased patient’s husband believed that signatures on certain consent forms may have been forged, and said that a handwriting expert may be called in. A hearing scheduled for Jan. 18 has been delayed due to new developments, according to the news organization.

Grekos is employed at Bonita Springs, Fla.-Regenocyte Therapeutic, a corporation specializing in stem cell therapies and regenocyte technologies.