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 Cells4health ALS Stem Cell Treatment
The ALS stem cell 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.
Almost 40% of the ALS patients treated with stem cells at Cells4health show improvement.
Patients are treated by injecting the stem cells into the bloodstream intravenously. Mannitol is administered to open the blood-brain barrier which allows the stem cells to reach the central nervous system.
IV-Mannitol is an outpatient procedure that requires patients to stay 4 or 5 nights.
Diagnostics, Physical and Cognitive Assessment
Before stem cell implantation, each patient undergoes blood tests at the clinic and a comprehensive physical and cognitive assessment. Baseline scores are calculated for Bernsden Standard Basic Functions, Barthel Index, Fruhreha Index and Modified Asworth Scale.
ALS patients may also undergo magnetic resonance imaging (MRI) in our high-resolution magnetic resonance scanner.
Step 1 – Bone Marrow Collection
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).
Step 2 – Laboratory Processing
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.
Step 3 – Stem Cell Implantation
The stem cells are implanted back into the patient by intravenous administration (IV) with Mannitol or by lumbar puncture.
A venous catheter is inserted into a vein in the right or left arm. Then the Mannitol is introduced over a 20 minute period. Mannitol is a safe, well-known drug that is used to open the blood-brain barrier in order to allow the passage of stem cells and other neurotropic factors into the brain and spinal canal. Next, the stem cells are slowly introduced into the catheter to allow them to thoroughly mix with the blood as they enter the body. No anesthesia is required for this procedure. However, anesthesia can be administered if necessary.
More detailed information on the IV-Mannitol procedure is available in the IV-Mannitol Informed Consent Document (PDF File).
A lumbar puncture is a puncture of the spinal canal using a fine needle, beveled at the front, in the lumbar region (lowest vertebrae of the back) of the spinal column for extracting spinal fluid (nerve or cerebral fluid). Lumbar punctures are primarily performed to diagnose for instance inflammatory disorders of the nervous system such as meningitis or multiple sclerosis. The extracted fluid, which is usually clear like water, in such cases is then examined in various ways in the laboratory.
During the LP for the stem cell therapy a volume of spinal fluid is extracted that is equivalent to the volume of your own stem cells intended for transplantation, so as little pressure difference as possible occurs in your spinal fluid space.
Changes in the pressure of the spinal fluid can cause headache. This pain is not dangerous and rarely lasts longer than 1 – 2 days, but the pain can be uncomfortable especially when getting up from a horizontal position due to the changing pressure ratios.
More detailed information on the LP procedure is available in the LP Informed Consent Document (PDF File).
Patients treated by IV-Mannitol or lumbar puncture may return home the day after IV treatment.
ALS Stem Cell Treatment Results
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.