BROOMFIELD, Colo. - A Broomfield stem cell clinic will continue to offer pain treatments to patients despite a government order to shut down some of their operations. Earlier this month, the Food and Drug Administration issued an injunction against Regenerative Sciences, claiming the facility was violating federal standards.
"We have no problem with the agency or how it conducts its business but we think they're wrong on this one," said Dr. Christopher Centeno, Regenerative Sciences Medical Director. "Clearly for many of our patients this is going to limit their treatment options."
The clinic takes stem cells from patients, grows them in a lab to create greater numbers, then reinjects them in the area of an injury to speed healing. The FDA believes by "culturing" these stem cells, the facility is manufacturing a drug without the proper licenses.
"They think that's a drug," Dr. Centeno said Friday. "We would obviously disagree with that. We think these are body parts, not drugs, and making them drugs isn't going to make them any safer for anybody."
Regenerative Sciences began culturing stem cells in 2005 and has treated roughly 500 patients using this method in the past several years. Among them is Hal Kaye, a 62-year-old Aurora man whose own cells helped heal an ankle that suffered severe blood loss and deteriorated following foot surgery.
"I walked with a cane most of the time," Kaye said about the period prior to the stem cell treatment. "It was excruciating and it limited my ability and my quality of life."
Two stem cell injections in 2008 helped him avoid bone fusion surgery and made him a new man.
"I play golf four to five times a week," Kaye said. "I walk on a treadmill two to three miles, three to four times a week... This procedure cured the pain 100 percent in the ankle."
Kaye believes the F.D.A. is wrong to stop this particular treatment.
"I think it's a crime that the government has taken the ability for this procedure to be done on people and put a halt to it for now," he said. "It's only there to help people and there's just no downside. I don't get it."
Centeno said cultured stem cell treatments involve fewer medical complications and much less downtime for patients. His clinic has sued the government four times already. His legal bills now total $400,000. He said he expects the case to eventually be resolved in court.
"This is a landmark case," he said. "I mean, this case will decide how physicians use stem cells for the next two decades."
By stopping the culturing of stem cells, Centeno said 50 patients who were in the process of receiving such treatments are now in limbo. He said some of them are quite angry. The clinic will continue to offer same-day stem cell injections for patients with smaller injuries.
"We have no problem with the agency or how it conducts its business but we think they're wrong on this one," said Dr. Christopher Centeno, Regenerative Sciences Medical Director. "Clearly for many of our patients this is going to limit their treatment options."
The clinic takes stem cells from patients, grows them in a lab to create greater numbers, then reinjects them in the area of an injury to speed healing. The FDA believes by "culturing" these stem cells, the facility is manufacturing a drug without the proper licenses.
"They think that's a drug," Dr. Centeno said Friday. "We would obviously disagree with that. We think these are body parts, not drugs, and making them drugs isn't going to make them any safer for anybody."
Regenerative Sciences began culturing stem cells in 2005 and has treated roughly 500 patients using this method in the past several years. Among them is Hal Kaye, a 62-year-old Aurora man whose own cells helped heal an ankle that suffered severe blood loss and deteriorated following foot surgery.
"I walked with a cane most of the time," Kaye said about the period prior to the stem cell treatment. "It was excruciating and it limited my ability and my quality of life."
Two stem cell injections in 2008 helped him avoid bone fusion surgery and made him a new man.
"I play golf four to five times a week," Kaye said. "I walk on a treadmill two to three miles, three to four times a week... This procedure cured the pain 100 percent in the ankle."
Kaye believes the F.D.A. is wrong to stop this particular treatment.
"I think it's a crime that the government has taken the ability for this procedure to be done on people and put a halt to it for now," he said. "It's only there to help people and there's just no downside. I don't get it."
Centeno said cultured stem cell treatments involve fewer medical complications and much less downtime for patients. His clinic has sued the government four times already. His legal bills now total $400,000. He said he expects the case to eventually be resolved in court.
"This is a landmark case," he said. "I mean, this case will decide how physicians use stem cells for the next two decades."
By stopping the culturing of stem cells, Centeno said 50 patients who were in the process of receiving such treatments are now in limbo. He said some of them are quite angry. The clinic will continue to offer same-day stem cell injections for patients with smaller injuries.
