In a case involving a criminal investigation into the recent death of a 77-year-old man after stem cell treatment, state health authorities say Dr. Zannos Grekos extracted tissue from the patient while a second doctor later injected the patient with his own concentrated stem cells.
But when Grekos, a Bonita Springs cardiologist, initially harvested fatty tissue from Richard Poling's stomach on March 2, he unknowingly damaged the patient's abdomen which led to bleeding, according to a state Department of Health complaint.
New documents obtained by the Daily News shed more light on the case of Grekos and Dr. Konstantine Yankopolus, a Fort Myers obstetrician who assisted Grekos. They face potential disciplinary action from the state Board of Medicine for doing a stem cell treatment that the state says was experimental and dangerous.
The state issued separate administrative complaints against them in late March and early April, a few weeks after Poling died the same day of the treatment. He suffered a cardiac arrest in Grekos' practice on Bonita Beach Road and was pronounced dead at NCH North Naples Hospital.
The Lee County Sheriff's Office launched a criminal investigation in early March and it is ongoing, agency spokesman Larry King said.
Grekos also faces potential discipline when the state restricted his license in February, 2011 in connection to the death of a 69-year-old woman who went to him in 2010 for stem cell therapy.
She sought a remedy for neurological damage after chemotherapy for breast cancer. She fell in her home after the treatment, suffered a brain injury and later was taken off life support.
The Collier County Medical Examiner's Office has declined to release the autopsy report of the woman's death, citing a law enforcement investigation.
The second patient, Poling, who lived in Newburgh, Ind., suffered from pulmonary hypertension. He paid $8,000 in hopes the stem cell treatment would help his condition.
Grekos medical staff suggested he have a first procedure to get stable so he could undergo further stem cell treatment in the Dominican Republic, according to the state complaint.
For years, Grekos has been sending patients with congestive heart failure or lung diseases to the Dominican Republic to have the therapy. Many of his patients stand behind him and say he has saved their lives.
On the morning of March 2 in his Bonita Springs practice, Grekos harvested fatty tissue from Poling's stomach, the state said. The fatty tissue contains stem cells.
Poling and his family were told to come back to the practice in five hours. By then, his blood would be back from a Boynton Beach laboratory where it would undergo a process to concentrate the stem cells, according to the state's complaint.
The treatment plan went awry when Poling felt pain and bloating by early afternoon. He returned to Grekos practice at 1:30 p.m. That's when Grekos found a hematoma, a collection of blood, in Poling's abdomen area but did not evaluate the patient further, according to the state.
Poling stayed at the practice and by late afternoon, his blood was back from the laboratory, the state said. That's when Grekos directed Yankopolus to infuse the stem cells intravenously into the patient. During the infusion, Poling went into cardiac arrest, the state complaint said.
Yankopplus could not be reached for comment Tuesday.
Although Grekos did not do the infusion himself, the state said his actions violated the earlier license restriction that he not do any treatments with stem cells or bone marrow aspirate.
Grekos has been fighting the license restriction and his defense attorney, Richard Ozelie, of Boca Raton, is expected to ask for a delay in a June hearing due to the state wanting to amend its original complaint.
In a recent motion, the state said it is no longer relevant that the FDA does not authorize or recognize stem cell therapy, which had been the basis of the original license restriction.
The state also is saying now that it is not relevant that the 69-year-old female patient hit her head the same evening in March, 2010, when she had the stem cell procedure in Grekos practice, according to the state's motion.
Instead, the state is arguing it found during discovery that Grekos had "abandoned" the patient twice, when she was discharged barely conscious after the stem cell treatment and when he failed to respond to three calls from her husband when her condition deteriorated, according to the motion.
The state said Grekos had disappeared and did not respond to calls after she was admitted to the hospital, according to the motion.
Ozelie is objecting to the state wanting to amend its original complaint, saying the allegations about the FDA or the patient hitting her head are "inextricably intertwined" with the defense strategy.
The state's license restriction against Grekos had relied on an expert who said he did an illegal stem cell therapy that is not authorized by the FDA.
"The FDA does not regulate autologous stem cell treatment," Ozelie said Tuesday, referring to the use of one's own stem cells.
Autologous stem cell treatment is done thousands of times and by different types of doctors to help patients with arthritis or other conditions.
"They are not prohibited from performing an autologous procedure or treatment," Ozelie said.
The state's original action against Grekos "is a case of first impression" based on an expert's statements which are not backed by the law, he said.