Article Details Randomized, Controlled Trial of Allogeneic
Mesenchymal Stem Cells in Patients With Non-ischemic Cardiomyopathy
Enrico Bastianelli, Chief Executive Officer of Bone Therapeutics commented: "Treating a patient for the first time with our allogeneic
The only option known to be curative is allogeneic
stem cell transplanatation, which carries a 25%-30% risk of treatment-relate mortality.
The goal of this study, led by principle investigator Michael Levy, MD, PhD, FACS, chief of pediatric neurosurgery at Children's Hospital San Diego (CHSD) and professor of neurological surgery at UCSD, is to determine tolerance and therapeutic outcomes for intravenously-delivered adult allogeneic
mesenchymal stem cells and to hopefully pave the way for a new therapeutic category of treatment for ischemic stroke.
The Company now concentrates its activities in the field of oncology through the development of Chimeric Antigen Receptor T-cell (CAR-T) immunotherapy products generated through its allogeneic
CAR-T platform, both on its own as well as in partnership with Servier and Pfizer.
The approval followed the FDA's decision to grant ATIR Orphan Drug Designation as a cell-based therapy for the reduction of TRM caused by GvHD and/or infections following allogeneic
bone marrow transplantation.
The study is designed to show reduction in transplant related mortality (TRM) after one year following an allogeneic
stem cell transplantation with a mismatched (haplo-identical) donor in blood cancer patients eligible for an allogeneic
stem cell transplantation but without having a matched donor available.
Figure 3: The applications of autologous and allogeneic
hematopoietic stem cell transplantation 11
Cellectis, a leader of allogeneic
CAR T-cell therapies, is pleased to announce it received a Scientific recommendation from the European Medicines Agency (EMA), in consultation with the European Commission, for UCART19, its lead product candidate in adoptive immunotherapy against CD19 expressing leukemias and lymphomas.
Exton, PA, announced the US Food and Drug Administration (FDA) has granted fast track designation for maribavir, an oral antiviral drug candidate for the prevention of cytomegalovirus (CMV) infection in allogeneic
bone marrow and solid organ transplants.
Multiple US medical centers activly enrolling patients into first Phase 2 trial of allogeneic
stem cells for congestive heart failure
received the FDA's investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its allogeneic
stem-cell therapy to treat subjects with mild to moderate dementia due to Alzheimer's disease (AD), the sixth leading cause of death in the United States.
Cellectis, a leader in the development of adoptive immunotherapies based on engineered allogeneic
CART cells (UCART) and CELLforCURE, the largest commercial industrial facility for the production of innovative therapeutic cell therapies in Europe, a subsidiary of the biopharmaceutical group LFB, announce that they have entered into an agreement for the cGMP manufacturing of clinical batches of Cellectis allogeneic
Exton, PA, announced it has initiated a Phase 2 clinical trial of maribavir, an oral antiviral drug that inhibits cytomegalovirus (CMV) in allogeneic
bone marrow transplant patients.
Analysis of factors secreted by these cells in the presence of inflammatory cytokines show the induction of several ligands, including B7-H1, which have been previously shown to enhance successful engraftment across allogeneic