It has come to the knowledge that the premiere organization Aldagen, Inc. which is based at Durham, N.C.-based., has in the recent days added three sites in respect of its clinical trial of ALD-301, a stem cell-based treatment meant for the critical limb ischemia. It is to be mentioned, that the three additional sites that have been recently added are the Duke University Medical Center (Durham, N.C.), Indiana University (Indianapolis, Ind.) and Saint Joseph's Research Institute (Atlanta, Ga.). While the original site involved in the trial is the Texas Heart Institute at St. Luke's Episcopal Hospital in Houston, Texas.

Now the question originates what has been the sudden need for the introduction of three added sites or what has been the central purpose? From the discourse with the responsible individuals in the different echelons of the Aldagen, Inc. it has been revealed that the Aldagen's clinical trial is destined to engage certainly not less than 20 patients, provided all of them will have their own bone marrow extracted. Among them there shall be a separate group of patients numbering up to ten who will receive a multiple number of injections of the bone marrow straightforwardly into the muscle in the ischemic leg, to be followed by another group having the same number of patients who will receive multiple injections of ALD-301. This shall be followed by a keen observation ranging up to six months with an endpoint in the crucial level at the end of three months.

But what are the endpoints? Endpoints in this very aspect will take account of safety and the ability of therapy that are thoroughly engaged in the reduction of rest pain, increasing of the skin surface oxygen pressure in conjunction with the enhancement in the healing of ulcer. Furthermore, according to Aldagen, ALD-301 is a strong population of stem and progenitor cells that remain cut off from the patient's bone marrow through the effectual utilization of the proprietary technology of the parent company.   ALD-301 is administered by means of intramuscular injections into the lower half of the leg of CLI patients.

Lastly when being enquired by the newsmen the Aldagen, Inc. clarified that the basic treatment is filled with a combination of all of the stem and progenitor cell types that are highly needed for CLI therapy together with endothelial, mesenchymal and neural progenitors.