Friday, July 26, 2013

CIRM’s Board approves Alpha clinics network to smooth road to stem cell clinical trials

In a much-anticipated move, the CIRM Governing Board gave the green light to a concept plan to develop a statewide network of Alpha stem cell clinics at yesterday’s Board meeting. The proposed plan will allocate $70 million to set up five clinics and a central coordinating center. The network will add momentum to the growing ranks of stem cell therapies headed to the clinical trials phase, as well as provide a meeting ground for the doctors and patients who will be part of the first phase of trials. You can read our press release about the vote here.

Therapeutic clinic networks already exist to offer treatments for diseases such as HIV or cancer, but clinic networks that treat a broad range of diseases, like CIRM’s Alpha stem cell clinics, are rare. DeWitt described the proposed clinics as “the go-to site for a variety of therapies.”

During the Board's discussion of the concept plan, Michael Friedman, President and CEO for the City of Hope, said of the new collaboration
“I think the timing on this is appropriate. I think the scope and scale sounds very reasonable to me. I think we have the opportunity to correct some things that other technology or disease areas have failed with in the past, such as – simple things, such as standardized data forms…so you don’t have problems with comparability and expensive ways of converting things, of establishing a culture of collaboration.”
Part of the challenge for stem cell therapies is that clinicians will need to ensure the stem cells are handled safely and that researchers have access to specialized equipment for tracking the cells inside patients’ bodies. Doctors will also need a way to follow-up patients after they’ve gotten the treatments. Establishing a network of institutions with this new capacity will smooth the path toward human stem cell therapies

The L.A. Times wrote about the clinics and quoted CIRM President Alan Trounson:
“If we went 10 years and had no clinical treatments, it would be a failure. We need to demonstrate that we are starting a whole new medical revolution.”
Natalie DeWitt, Special Projects officer and Maria Milan, Medical Officer, who presented the proposal to the Board, emphasized that the clinics would build on the chosen institutions’ existing resources -- such as research and clinical expertise as well as equipment and space -- for a stem cell clinic. Their background material is available on the meeting's agenda. DeWitt also wrote about the concept for the clinics in a recent blog entry.

In her presentation, DeWitt started with a video made at a workshop in which an international group stem cell and clinical experts met to discuss the unmet needs of researchers hoping to deliver stem cell clinical trials. The concept approved yesterday came out of that discuss. The video is here, and a white paper produced from the workshop is here.

The second arm of the Alpha stem cell clinic network will be a central coordinating center that would be a clearinghouse for stem cell clinical trials. It would provide expertise about the best way to shepherd new treatments through the clinical trial phase.

Milan said the effort will take CIRM to its next phase, which is bringing stem cells to the clinic.

Another major goal of the initiative is to provide reliable information to the public. Right now, patients and their families have few resources to help them navigate the sea of questionable information about stem cells, much of it available online. The Alpha stem cell clinic network would distribute information about potential clinical trials both in the network and outside of it.

CIRM plans to release a Request for Proposals (RFA) for the clinics in October 2013 (that RFA will be available here).

Rina Shaikh-Lesko

2 comments:

  1. Better hurry up...it looks like Europe is more serious about curing people than the over bloated US Medical complex....


    July 29, 2013

    BrainStorm’s NurOwn Cell Therapy Receives Orphan Drug Designation in the European Union for ALS

    NEW YORK & PETACH TIKVAH, (Israel) – July 29, 2013 - BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that the European Commission has granted Orphan Drug Designation for NurOwn™, the Company's stem cell therapy consisting of autologous bone marrow-derived mesenchymal stromal cells secreting neurotrophic factors, for the treatment of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s Disease. NurOwn received Orphan Drug Designation from the Food and Drug Administration (FDA) in 2011.

    Orphan drugs benefit from 10 years market exclusivity in the European Union (EU) after marketing approval. Additional benefits for sponsor companies include reduced fees for various centralized activities including applications for marketing authorization, inspections and protocol assistance, as well as possible eligibility for EU grants and other R&D-supporting initiatives.

    BrainStorm is currently conducting a Phase IIa dose-escalating trial with 12 ALS patients at the Hadassah Medical Center in Jerusalem, Israel. The company anticipates launching a Phase II multi-center trial at three leading institutions in the United States towards the end of 2013, pending FDA approval.

    http://www.brainstorm-cell.com/index.php/news-a-events/company-news/263-july-29-2013

    keep stalling...and extracting from the vulnerable.

    ReplyDelete
  2. I think stem cells should be continuously improved through clinical trials because it has a potential of helping lots pf people.

    ReplyDelete