US-based biotechnology company Stemedica Cell Technologies has begun enrolment for its new Phase IIa trial of allogeneic, human mesenchymal stem cells to treat Alzheimer's disease (AD).
Mesenchymal stem cells (MSCs) are multipotent cells that can occur in several adult tissues.
The Phase IIa trial is designed as a multicentre, randomised, single-blind, placebo-controlled crossover study.
It is aimed at evaluating the safety, tolerability and a preliminary efficacy of the allogeneic human mesenchymal stem cells administered in a single intravenous dosage to treat mild to moderate dementia caused by AD.
The trial is planning to enrol about 40 subjects displaying mild to moderate dementia due to AD diagnosed three months before the enrolment.
Stemedica Cell Technologies chief regulatory and clinical development officer Lev Verkh said: "This study is based on exciting preclinical data, which demonstrated that intravenous administration of Stemedica stem cells resulted in a delay of accumulation of plaque formation and also in the reduction of plague in an animal Alzheimer's model.
“This exciting data has been presented at several international meetings.
"We are also encouraged by an excellent safety profile of our cells as demonstrated in several ongoing clinical trials conducted by Stemedica and Stemedica affiliates under the US Investigational New Drug (IND)."
According to Emory University School of Medicine associate professor of medicine and neurology Ihab Hajjar and Emory Alzheimer's Disease Research Centre investigator, the trial will explore new therapeutic options offered by the stem cells and address the limited options of treatment of AD.
Image: Normal brain compared to brain condition during severe Alzheimer's Disease. Photo: courtesy of National Institutes of Health.