Participants in a Federal Drug Administration (FDA) protocol at TCA Cellular Therapy utilizing stem cells to treat lower limb ischemia are experiencing increased mobility and decreased pain in lower legs.
Lower limb ischemia is a condition where plaque build-up causes decreased circulation in the lower leg. Symptoms of the condition include intense pain and swelling.
Study participants may have had different factors that contributed to their condition: a family history of Peripheral Artery Disease (PAD), history of smoking, and other vascular conditions.
Common among them however, were that more traditional treatments (utilizing stents and grafts) were ineffectual and that the patients were losing their ability to continue their daily activities.
Meryl Sharp was an avid gardener before she had to give up the hobby last year. She could no longer walk the length of the lawn without stopping to rest her throbbing legs. "It got to the point where the intervals of rest were not even enough to ease the pain," she said.
The study participants were referred by their vascular surgeons to TCA Cellular Therapy, where Gabriel Lasala, M.D. and Jose Minguell, Ph.D. have been authorized by the FDA to study the safety and efficacy of stem cell therapy for lower limb ischemia.
"The similarity in the recovery of our patients is promising," said Dr. Lasala. "We find that the stem cells, once re-injected, go about forming new blood vessels, thus increasing circulation dramatically."
Drs. Lasala and Minguell have developed a treatment where a patient's own stem cells are taken from the hip, grown in a sterile environment, and then re-infused into 38 areas of the leg.
So far, 10 patients have received the stem cell treatment for peripheral vascular disease.
"Patients are experiencing increased mobility within weeks of their infusions. The continued improvement throughout their recoveries is a positive sign," Lasala said.
Carleton Wert could only walk 2-1/2 minutes on the treadmill before he underwent the stem cell therapy. At his 3-week check-up, he clocked 4 minutes. Within 2 months, his time improved to over 10 minutes.
Similarly, Michael Pearl could not even undergo the treadmill test prior to his infusion in mid-November because his pain was so intense. He went from walking 5 minutes at his 1-month check-up to 18 minutes at the 3-month mark.
With increased mobility, Dr. Lasala's patients are resuming their normal routines. Wert, who was on disability because of the ischemia, is now seeking employment. Sharp has gone back to gardening, creating a new antique garden with her husband in their front yard.
Perhaps most striking is the transformation experienced by Penny Kibideaux. Running out of options to treat her ischemia, Kibideaux had already scheduled a leg amputation. Under the advice of her physician, Kibideaux went to see Dr. Lasala. Not only has he saved her leg, Kibideaux says he has saved her life. Just weeks after her November infusion, she walked several shopping malls as part of her Christmas shopping. She has also recently taken up line dancing.
The FDA protocol study will continue for the next 2 years, after which Dr. Lasala expects that stem cell treatment for lower limb ischemia will be widely utilized in the medical community.
"We are excited that our patients are responding well to the treatment," he said. "We hope that more people will be able to experience relief and improve their quality of life through this procedure."
Illustration: TCA Cellular Therapy.
Earth Times (05/29/08)
Business Network (05/29/08)
TCA Cellular Therapy
Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia (mesendo) Phase I Clinical Trial