Parkinsonism

Historically, the standard treatment for Parkinson disease (PD) has been to enhance dopamine levels by administering levodopa, a dopamine precursor. However, this has adverse long-term side effects such as dyskinesias and “on–off” fluctuations. Moreover, because of the degenerative nature of the disease, it can only be controlled, not cured. Therefore, as dopamine replacement does not slow down the rate at which neurons are lost, it is necessary to increase dosages or introduce new medication, such as anticholinergic agents or selective monoamine oxidase B inhibitors. Other treatments include surgical procedures such as pallidotomy or deep brain stimulation. Pallidotomy is the destruction of a tiny part of the globus pallidus, reducing neuronal activity in that area, whereas deep brain stimulation works as a “pacemaker for the brain” by stimulating the affected neurons. Both procedures are intended to relieve movement

Stem cells from bone marrow have shown the ability to differentiate into neurons and other tissues. Although these cells will migrate to sites of injury, they do so in very small quantities and are therefore unable to play a role in regeneration. In this study, we aim to use this physiologic reality and enhance it. We will do so by delivering large numbers of mononuclear fraction of autologous stem cells to the affected area with the use of super selective arterial catheterization through the basilar artery, with the goal of providing significantly higher concentrations of stem cells very close to the affected area than could be achieved with the venous peripheral approach. Our objective is to ensure that stem cells are able to reach the substantia nigra and differentiate or help the dopaminergic neurons through paracrine action and thereby restoring normal function. In addition, this is a minimally invasive procedure compared with the stereotaxic approach. We will be reporting the results of this technique with regard to motor and central neural function, as well as quality of life (QOL).

In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells after super selective intra-arterial implantation in patients with Parkinson’s disease.

You will be evaluated with clinical and neurologic examinations; internationally recognized scales for the evaluation of Parkinson’s disease, disability, activities of daily living, depression, and quality of life (QOL); as well as videos, magnetic resonance (MR) imaging, and MR spectroscopy.

We will be treating your Parkinsonism with mononuclear fraction stem cells derived from the bone marrow taken from iliac crest. Treatment can be either done in India or Trinidad.

We will be doing femoral catheterization to reach the basilar trunk, posterior cerebral arteries and the posterior Circle of Willis, from which originate the perforating arteries that supply the basal nucleus and the substantia nigra. These four areas within the brain are the locations of the super selective intra-arterial injection of bone marrow derived mononuclear cells.

The treatment length would be as follows: 1 intra-arterial infusion with follow-up of another 7 days as direct observation before the discharge.

Our staff members will follow you up in accordance to the study protocols. 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.

Neurologic evaluations will be conducted during hospitalization at 12 and 72 hours after stem cell implantation and prior to discharge. Efficacy evaluation will be performed with the internationally recognized scales for the evaluation of Parkinson’s disease, disability, activities of daily living, depression, and quality of life (QOL) for Parkinson’s at 1 and 2 weeks and 1, 3, 6, and 12 months after stem cell implantation. Video data will be obtained with your consent during follow-up. Functional and metabolic neural response at 12 months as compared to baseline will be observed by magnetic resonance (MR) imaging of the brain with perfusion, apparent diffusion coefficient (ADC) map, and multivoxel cerebral spectroscopy done at baseline and after 12 months of treatment.