This week TCA Cellular Therapy`s Medical Director Gabriel Lasala, M.D. presents advances in adult stem cell treatments for severe limb ischemia and refractory coronary ischemia at the European Society of Cardiology Congress in Barcelona, Spain.
TCA Cellular Therapy is the only company in the world utilizing two different types of adult stem cells to treat cardiac and vascular conditions.
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. Lasala, together with the company`s Scientific Director Jose Minguell, Ph.D., treated 33 patients during the Phase I and Phase II safety/efficacy clinical trials using a combination of the patient`s own endothelial progenitor cells (EPCs) and mesenchymal stem cells (MSCs). The cells, obtained through bone marrow aspiration, were mixed and infused in areas with damaged blood vessels to develop mature stable vessel formation in ischemic limbs.
According to Lasala, there were no adverse effects as a result of the infusions. More importantly, their patients experienced a progressive improvement in all clinical parameters which are still persisting a year after treatment. "All patients experienced improvement in their walking tests, ankle brachial pressure index, oxygen pressure, angiography and quality of life," Lasala said.
Coronary Ischemia (CI) is intractable angina due to severe coronary artery disease which can seriously decrease blood flow to the heart.
Drs. Lasala and Minguell completed the Phase I protocol last year and is currently conducting Phase II involving 60 patients.
According to Lasala, six months following Phase I cell infusions, a significant improvement in the quality of life was observed in all patients. The results suggest that recruitment of new capillaries could be a leading event involved in the improvement of CI. This study was the first to demonstrate the infusion of the combination cell product was safe and feasible.
The formation of new mature blood vessels with the ability to appropriate blood supply to the heart is complex and requires participation of several types of adult stem cells and growth factors. The Phase II study further investigates the safety and efficacy of intracoronary infusion of a combination cell product.
"These findings, coupled with increase of blood flow in collateral vessels, suggest that the therapy is both safe and effective," stated Lasala.
The researchers believe that the use of adult stem cell therapy in limb and coronary ischemia patients allows for the development of new mature and stable capillaries.
"The similarity in the recovery of our patients is promising," said Lasala. "We find that the stem cells, once re-injected, go about forming new blood vessels, thus increasing circulation dramatically."
TCA Cellular Therapy is the only company in the world utilizing two different types of adult stem cells to treat cardiac and vascular conditions.
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. Lasala, together with the company`s Scientific Director Jose Minguell, Ph.D., treated 33 patients during the Phase I and Phase II safety/efficacy clinical trials using a combination of the patient`s own endothelial progenitor cells (EPCs) and mesenchymal stem cells (MSCs). The cells, obtained through bone marrow aspiration, were mixed and infused in areas with damaged blood vessels to develop mature stable vessel formation in ischemic limbs.
According to Lasala, there were no adverse effects as a result of the infusions. More importantly, their patients experienced a progressive improvement in all clinical parameters which are still persisting a year after treatment. "All patients experienced improvement in their walking tests, ankle brachial pressure index, oxygen pressure, angiography and quality of life," Lasala said.
Coronary Ischemia (CI) is intractable angina due to severe coronary artery disease which can seriously decrease blood flow to the heart.
Drs. Lasala and Minguell completed the Phase I protocol last year and is currently conducting Phase II involving 60 patients.
According to Lasala, six months following Phase I cell infusions, a significant improvement in the quality of life was observed in all patients. The results suggest that recruitment of new capillaries could be a leading event involved in the improvement of CI. This study was the first to demonstrate the infusion of the combination cell product was safe and feasible.
The formation of new mature blood vessels with the ability to appropriate blood supply to the heart is complex and requires participation of several types of adult stem cells and growth factors. The Phase II study further investigates the safety and efficacy of intracoronary infusion of a combination cell product.
"These findings, coupled with increase of blood flow in collateral vessels, suggest that the therapy is both safe and effective," stated Lasala.
The researchers believe that the use of adult stem cell therapy in limb and coronary ischemia patients allows for the development of new mature and stable capillaries.
"The similarity in the recovery of our patients is promising," said Lasala. "We find that the stem cells, once re-injected, go about forming new blood vessels, thus increasing circulation dramatically."