Hi all,
I made a mistake with the title of this thread: Brainstorm is
expecting to start
ALS trials in 2010, but it still has to approved for my the Israel Ministry of Health. They, are at this time, gearing up for final preclinical safety studies that will then allow them to apply for the trials, which they expect to start next year. Sorry for the mistake. However, that shouldn't detract from the promising work they are conducting, as explained in the following statement:
Brainstorm Announces Milestone Towards ALS Clinical Trials
Brainstorm Announces Milestone Towards
ALS Clinical Trials
NEW YORK & PETACH TIKVAH, ISRAEL--(BUSINESS WIRE)--BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI), a leading developer of adult stem cell technologies and therapeutics, announced today that bone marrow cells taken from
ALS patients were capable of differentiating into nerve-supporting cells.
The company tested
ALS patients' bone marrow stem cells in order to confirm that these stem cells could undergo BrainStorm’s differentiation procedure to secrete NeuroTrophic Factors (NTF) and used for treatment by back transplantation into the patients.
The experiments performed at BrainStorm Cell Therapeutics’ research laboratories showed that the stem cells isolated from bone marrow of healthy donors and
ALS patients were similar, as indicated by all the morphological and biochemical parameters tested. In addition, the cellular expansion potential of stem cells from the healthy donors and from the patients was comparable. Most important, cells from both, the healthy donors and the patients, secreted NeuroTrophic Factors (NTF) after applying Brainstorm’s unique differentiation protocols.
BrainStorm will now complete all of its preparations for pre-clinical trials to be followed by clinical trials based on the company's proposed stem cell therapy.
Prof. Daniel Offen, Brainstorm’s Chief Scientist, said: ”The differentiated stem cells express specific proteins characteristic of brain (glial) cells and secrete NeuroTrophic Factors (NTF) , such as GDNF and BDNF, which are essential for survival of existing neurons and encourage the growth and regeneration of new neurons”.
He added that “Our results show that
ALS patient's cells are capable of undergoing expansion and differentiation. Hence, it appears that bone marrow derived stem cells from
ALS patients may be beneficial for therapy through autologous (self) transplantation, using Brainstorm Cell Therapeutics’ process."
As previously announced, Brainstorm has now begun the process of growing its NTF cells according to the regulatory authority standards at Protein Production Services (PPS) Ltd facilities. BrainStorm plans to proceed with final pre-clinical studies at Harlan Biotech Israel Ltd (HBI) whereby Brainstorm will be ready to submit an application for human clinical trials in Israel to the Ministry of Health.
Mike