Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic lateral sclerosis (ALS) also known as Lou Gehrig's disease and Charcot disease is characterized by progressive degeneration of motor neurons in the cortex, brainstem and spinal cord resulting in paralysis and death within an average of 3 to 5 years from disease onset. Amytrophic means muscles with no nourishment; lack of impulses to the muscle due to dying nerve cells renders atrophy to muscle tissue. Lateral sclerosis means hardening of lateral columns of the spinal cord where the motor nerve cells are located. The progressive degeneration of the motor neurons in ALS eventually leads to their demise. People may gradually loose ability to speak eat and finally breathe.

The majority of ALS cases are of unknown etiology and sporadic in nature (90–95%) with no genetic association. However, familial ALS (fALS) also exists ALS patients experience upper limb, lower limb or bulbar onset, with variable involvement of upper and lower motor neurons and subsequently differing rates of disease progression . This heterogeneity of ALS makes it difficult to identify the mechanisms of disease origin and to develop successful therapies. Currently, ALS has no available pharmacological treatment options that offer long-term efficacy.

Nervous system has limited regenerative potential. Stem cells derived from adult source, as well as placental tissues have been successfully probed to generate tissues of the nervous system during disease conditions. The rationale for use of adult stem cells as a treatment for neurological diseases such as ALS arose from the hope that they had the capacity to foster repair of the CNS through tissue integration and differentiation into neural cells.

Mesenchymal stromal cells (MSCs) are multi-potent cells that have the capability of differentiating into adipogenic, osteogenic, chondrogenic and neural cells. With these multiple capabilities, MSCs have been highly regarded as an effective transplantable cell source for regenerative medicine. Evidence from preclinical studies suggested that mesenchymal stem cells (MSCs), a subset of adult progenitor cells, are an effective therapy in preclinical animal models of neurological diseases. Surprisingly, these effects do not require full CNS engraftment by MSCs, but rely on the capacity of MSCs to inhibit pathogenic immune responses and release neuroprotective and pro-oligodendrogenic molecules favoring tissue repair. Small clinical studies in different neurological diseases have suggested that MSCs are safe.

In our present study, we want to evaluate the safety and efficacy of antilogous bone marrow derived stem cells or allergenic mesenchymal stem cells after super selective intravenous and intrathecal administration in patients with Amyotrophic Lateral Sclerosis.

Assessment of treatment safety will be based on incidence of any treatment emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months post treatment.

We will be treating your ALS from either mononuclear fraction stem cells derived from the bone marrow or cord tissue derived mesenchymal stem cells. Bone marrow antilogous stem cells treatment can be done either in Trinidad or India and cord tissue derived mesenchymal stem cells will be used if the treatment is planned in Trinidad.

We will be doing internal jugular catheterization and super selective intravenous injection of either bone marrow derived mononuclear cells or cord tissue derived mesenchymal stem cells along with liberation procedure (when associated with CCSVI). This dose is followed by intrathecal administration of bone marrow derived mononuclear cells or cord tissue derived mesenchymal stem cells.

The treatment length would be as follows: Two infusions, 1st would be jugular vein angioplasty along with stem cell infusion, and 2nd will be lumbar puncture infusion, 7 days apart with follow-ups of another 7 days as direct observation before the discharge.

Our staff members will follow you up in accordance to the study protocols. Each study protocol will be discussed with you. We will also collaborate with your neurologist to monitor your disease status and also provide you with assistance to conduct MRI scans in your home country. Our medical staff will be monitoring you 1,3,6 and 12 months after treatment.