Stem cell treatment of Amyotrophic Lateral Sclerosis
Introduction
If you or a loved one is suffering from ALS, then you are probably aware that there is no cure. The average life expectancy from diagnosis is 2 - 5 years.
Amyotrophic lateral sclerosis (ALS), often referred to as "Lou Gehrig's Disease," is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. The progressive degeneration of the motor neurons in ALS eventually leads to their death. When the motor neurons die, the ability of the brain to initiate and control muscle movement is lost. With voluntary muscle action progressively affected, patients in the later stages of the disease may become totally paralyzed.
The US FDA has approved the drug Riluzole for the treatment of ALS. Riluzole prolongs survival in some patients for up to several months. However, there is no standard medical treatment that can reverse the debilitating effects of ALS or offer patients any medium-term or long-term improvements.
The Xcell-Center ALS Treatment
The XCell-Center's ALS treatment focuses on reducing symptoms and slowing down the chronic consequences of ALS in order to improve each patient's quality of life. The mechanism of how the stem cells work is not yet understood.
Patients are treated by injecting the stem cells into the cerebrospinal fluid which flows within the spinal canal. This procedure is called intrathecal injection or lumbar puncture.
Lumbar puncture is an outpatient procedure that requires patients to stay in Germany 4 or 5 nights.
In a pilot study, almost 40% of the ALS patients treated with stem cells at the XCell-Center showed improvement.
The entire treatment consists of three steps: bone marrow collection, laboratory processing and stem cell implantation.
Bone Marrow Collection
On the
first day, bone marrow is collected from the patient's iliac crest
(hip bone) using thin-needle mini-puncture under local anesthesia.
Although some pain is felt when the needle is inserted, most
patients do not find the bone marrow collection procedure
particularly painful. The entire procedure normally takes about 30
minutes.
Once the bone marrow collection is complete, patients may return to their hotel and go about normal activities.
More detailed information on the bone marrow collection procedure is available in the Bone Marrow Informed Consent document (PDF file).
Laboratory Processing
The next
day, the stem cells are processed from the bone marrow in a
state-of-the-art, government approved (cGMP) laboratory. In the
lab, both the quantity and quality of the stem cells are measured.
These cells have the potential to transform into multiple types of
cells and are capable of regenerating or repairing damaged
tissue.
Stem Cell Implantation
On the third day, the stem cells are implanted back into the patient by lumbar puncture.
A spinal needle is inserted between L4 and L5 vertebrae under local anesthesia and a small amount of spinal fluid is removed. A portion of that spinal fluid is mixed with the stem cell solution which is then injected into back into the patient's spinal fluid, not the spinal cord. After the stem cells have been implanted, the patient will lie down in the recovery room for a few hours before returning to his or her hotel room. Normally, the lumbar puncture procedure is not painful.
Following Treatment
Patients treated by lumbar puncture are required to stay in town on the day after their procedure for general safety purposes. They may return home on the fifth day.
Results
A total number of 32 patients with ALS were
treated and returned the post treatment questionnaires.
Improvements were reported in 50% of the patients. Most patients reported improvements in muscle strength (56.3%), sensory function (37.5%) and motor function (30.4%). Also more than 25% of the patients reported better fine motor skills. Furthermore, our patients reported improvements in speech (25%), eating (25%), bladder/bowel control (12.5%), mental state (18.8%), breathing (12.5%), and weight control (25%).
Click to view or print complete ALS results inluding graphs (pdf)
For safety information on 870 patients treated by lumbar puncture, please view our Lumbar Puncture Safety Statistics (PDF file).
Cost
Stem cell implantation via lumbar puncture: 7,995 Euros
Treatment Evaluation Process
In order to be evaluated for treatment, patients must complete an online medical history form. Once you've completed the online medical history and submitted it, a patient relations consultant will contact you. He or she will assist you with the rest of the evaluation process. Upon treatment approval, your consultant will also assist you with treatment scheduling and trip preparation.
