PARKINSON STEM CELLS
Stem cell derived Parkinson’s disease treatment has been given to the 10th patient in an Australian clinical trial from International Stem Cell Corp.
In a surgery performed without complications at the Royal Melbourne Hospital the patient received brain cells derived from the company’s proprietary stem cell product that were introduced into the brain. Similar transplants have been performed using fetal brain cells, however the company uses its own proprietary stem cells, patients getting this experimental therapy are being examined carefully for any side effects.
This patient was the 2nd of three groups of a patients with Parkinson’s disease, each group has received varying doses of the stem cells; this group is receiving 70 million cells which is the highest dose yet given; last patient from this grouping is expected to receive treatment by the end of 2018.
Russell Kern, executive vice president and chief scientific officer says in a statement that based on available clinical data they are confident the therapy is safe, well tolerated, and has the potential to improve quality of patient life.
This is an early stage study meant to judge safety in treating the disorder. The company has said that there are preliminary signs of treated patients showing benefit, but this will need to be confirmed with more advanced studies.
The company’s proprietary stem cell treatments are derived from unfertilized or parthenogenetic human egg cells that are grown into neural stem cells capable of becoming various kinds of cells in the brain, that have been immune matched to reduce chances of being rejected. After transplanting the neural stem cells are intended to mature into cell types that will relieve symptoms such as neurotransmitter dopamine cells that are destroyed in the disease, and others are expected to become cells that support that dopamine making neurons.
San Diego County, Summit For Stem Cells is also attempting a similar therapy. A major difference is these stem cells being used are derived from the patients being treated, making them immune compatible, which are grown into stem cells that are then converted into dopamine making neurons; only these dopamine making cells are transplanted.
Six patients have now fully completed the study and entered the follow-up phase while two other patients have completed the six-month evaluation. The treatment phase of the study will conclude following the dosing of the last two patients of the third cohort, which ISCO plans to complete soon.
About the clinical study
The Phase I clinical study is a dose escalation safety and preliminary efficacy study of ISC-hpNSC®, intracranially transplanted into patients with moderate Parkinson's disease. The open-label, single center, uncontrolled clinical trial will evaluate three different dose regimens of 30,000,000 to 70,000,000 neural cells. A total of 12 participants with moderate-to-severe Parkinson's disease will be treated. Following transplantation, the patients will be monitored for 12 months at specified intervals to evaluate the safety and biologic activity of ISC-hpNSC®. A PET scan will be performed at baseline, as part of the screening assessment, and at 6 and 12 months after surgical intervention. Clinical responses compared to baseline after the administration of ISC-hpNSC® will be evaluated using various neurological assessments such as Unified Parkinson Disease Rating Scale (UPDRS), Hoehn and Yahr and other rating scales. An extension phase of the study will evaluate patients every 6 months for 5 additional years.