Parkinson’s Patients Enrolling in Novel Stem Cell-Based Clinical Study

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by Maureen Newman |

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A currently enrolling clinical study observing Parkinson’s disease patients seeks to determine if those with the disease can benefit from the potential power of stem cells. The study, “Outcomes Data of Adipose Stem Cells to Treat Parkinson’s Disease,” is currently recruiting participants, and clinicians have begun to administer the investigative new therapy to already enrolled participants. The study was initiated in July 2014 and is expected to end in June 2017.

“The study we are conducting is designed to provide us with a large amount of rigorously collected data so that we can better understand the clinical benefit of Parkinson’s patients treated with stem cells,” stated StemGenex in a news release.

The study hopes to expand on the body of scientific knowledge about the role of stem cells in Parkinson’s disease patients. According to StemGenex, it is already known that dopaminergic neurons in the brains of Parkinson’s disease patients are not fully functional and cannot properly control movement through dopamine release. Stem cell therapies, such as the one being designed and applied by StemGenex, seek to boost the pool of dopamine in the brain by delivering autologous (patient’s own) adipose-derived stem cells to areas of damage. It is believed that when the stem cells differentiate, they can create new dopamine-producing neurons. Additionally, the delivered stem cells may release natural cytokines that induce differentiation of resident adult stem cells in the brain into dopamine producing neurons.

“Parkinson’s disease affects a very small part of the brain, but anyone suffering with this disease understands the negative impact on his or her life is very big, actually, enormous,” said Rita Alexander, founder and President of StemGenex. “Over the last several years we have observed significant improvement in the symptoms of Parkinson’s patients through stem cell treatment. We are determined to be part of the solution and are eager to document and publish our findings in the next few years.”

For this particular study, the next few years will involve continued patient enrollment, observing those treated with the regimen outlined in the clinical study design. An enrollment target of 75 patients age 18 years or older is well underway.

Evaluation of the success of stem cell therapy is based on the Parkinson’s Disease Questionnaire (PDQ-39), or a test of overall quality of life. As explained by University of Oxford Isis Innovation, the test is considered to be the most comprehensive test of benefits to individuals with Parkinson’s disease who are undergoing treatment in a study or a clinical trial. Thirty-nine questions are used to evaluate self-image and sexuality, patient outlook, physical function, social and role function, quality of sleep, independence, urinary function, and global health-related quality of life. Secondary outcomes of this study involve the individual components of the PDQ-39, evaluated as a change from baseline at month 12. Evaluating these changes and statistics collected will allow researchers to determine if this mode of care is a viable, safe and effective option.

Patients have reported seeing changes in some of the most common symptoms of Parkinson’s disease — both primary and secondary motor symptoms and also non-motor symptoms. These symptoms include resting tremors, slow movements, rigidity, postural instability, difficulty swallowing or speaking, mood disorders, and vision problems. Many of these symptoms can be managed by standard Parkinson’s disease treatments, but treatment options are limited.  The handful of drugs that are available can only ameliorate symptoms and unfortunately, prolonged usage can create terrible side effects. Further, these drugs do not halt disease progression or aid in the repair of established damage.

The outcomes of the current observational study, as well as other future studies exploring the potential efficacy of stem cell therapy, will shed new light on how this possible new treatment approach is beneficial in the context of Parkinson’s disease. Participation in studies such as these and clinical trials is vital to enable the development of promising treatments for the disease.

To learn more about participating in stem cell therapy clinical studies for PAR, visit the StemGenex website.

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