Sent: Mon, 25 Oct 2004 16:39:57 -0700
From: "The ALS Association"
Subject: News from ALSA: Stem Cell Treatments in China

Clinical Update: Stem Cell Treatments in China

Many in the ALS community are looking for more information about the stem cell treatments being provided in China. At this time, there is not sufficient information about Dr. Huang Hangyun’s work in China to indicate with scientific certainty that the treatment is safe and effective.

Researchers and clinicians advise The ALS Association that it is premature to recommend this treatment for people with ALS. Although it is disappointing to all of us not to have definitive and positive results, The ALS Association will continue the dialogue and review Dr. Huang’s study results when they are presented.

While we are looking for encouraging news about the use of stem cells as an effective treatment for ALS, this is not a simple process.

Potential future use of stem cells for people with ALS remains a topic of enthusiastic and focused research in the United States and throughout the world. The work to answer key scientific questions and overcome inherent challenges to the treatment is moving forward. At the International Symposium on ALS/MND in November, results of several stem cell research studies in ALS will be presented. ALSA will provide a summary of these research reports on our web site following the symposium (www.alsa.org).

In September 2004, Dr. Huang met with a small group of ALS researchers to discuss the stem cell transplantation he has conducted. Dr. Lucie Bruijn, ALSA’s science director, attended this meeting and asked Dr. Huang several questions. Little new information was learned about Dr. Huang’s procedure, and The ALS Association will continue to monitor any news or further progress. A summary of the information ALSA has to this date is listed below.

• Dr. Huang reports that he has treated 40 people with ALS using spinal cord and forebrain injections, each including 1 million olfactory ensheathing cells. He began his work in this area by transplanting olfactory ensheathing cells into 171 people with spinal cord injury.

• There were no data presented from the patients with spinal cord injury to demonstrate the effects - positive or negative - on any of these patients. Video clips were shown for a total of eight ALS patients before and after treatment. Two patients did not demonstrate any change in their condition after transplantation. Data for the remaining patients was absent and no long term follow-up data on patients was provided. Without peer review of objective data on each patient before, immediately after and at specific long-term points following the transplantation, the study lacks sufficient scientific evidence to demonstrate that the treatment is safe and effective.

• Dr. Huang reported that within both patient groups (those with spinal cord injuries and ALS), there was rapid improvement of partial function.

There were no data or information presented about the long term effects of the treatment.

• A placebo response to treatment is a well-documented medical phenomenon. Without objective, long-term data collection and/or controls, it is very difficult to conclude with any scientific certainty that the treatment is responsible for the positive response.

• ALSA staff members have spoken with several patients with ALS who have received the transplantation and their family members. Initial responses have included the return of some function shortly after the
transplantation, but it is unclear how long the initial effects last.

• It has been reported that the procedure costs between $10,000 and
$20,000 in addition to travel and lodging expenses. Patients are required to stay for at least five weeks.

The ALS Association remains hopeful and encouraged about the possible future use of stems cells in the treatment of ALS. By continuing rigorous and high quality research, the answers about if and how stem cells can be used effectively in ALS will come. Early treatment efforts that are negative or inconclusive should not dampen the quest for scientifically valid answers and pursuit of stem cells for ALS.

See more information on stem cells written by Lucie Bruijn, Ph.D. at
http://www.alsa.org/research/stem_cells.cfm.

The ALS Association
27001 Agoura Road
Suite 150
Calabasas Hills, CA 91301
818-880-9007
www.alsa.org