ISC-hpNSC / International Stem Cell Corp - LARVOL DELTA

A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's Disease (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Cyto Therapeutics Pty Limited | Unknown status ➔ Completed | Trial completion date: Jun 2020 ➔ Sep 2025 | Trial primary completion date: Apr 2020 ➔ Jun 2025

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

International Stem Cell Corporation Announces Successful Completion of Its Phase 1 Clinical Trial in Parkinson’s Disease (Issuer Direct) - P1, N=12; NCT02452723; Sponsor: Cyto Therapeutics Pty Limited; "International Stem Cell Corporation...successful completion of its dose escalating phase 1 clinical trial...evaluating the safety, tolerability and preliminary efficacy of its lead candidate, ISC-hpNSC®...In terms of preliminary efficacy, where scores are compared against baseline before transplantation, we observed a potential dose-dependent response, with an apparent peak effectiveness at our middle dose. The % OFF-Time...decreased an average 47% from the baseline at 12 months post transplantation in cohort 2. This trend continued through 24 months where the %OFF time in the second cohort dropped by 55% from the initial reading....The % ON-Time increased an average of 42% above the initial evaluation at 12 months post-transplantation in the second cohort. The %ON result improved in the second cohort to 65% above the baseline in month 24."

P1 data • Trial completion • CNS Disorders • Parkinson's Disease

Transplantation of neural stem cells for parkinson’s disease, an update of the first-in-human clinical study (Neuroscience 2016) - P1; "Secondary endpoints evaluate clinical responses compared to baseline using several neurological assessments, 18F-dopa PET and MRI. We expect that ISC-hpNSC will be safe, well tolerated and might even slow down PD progression."

Biosimilar • Gene Therapies • Parkinson's Disease

Human parthenogenetic neural stem cell grafts promote multiple regenerative processes in a traumatic brain injury model. (PubMed, Theranostics) - "Furthermore, histological analyses indicated that high and moderate doses of stem cells increased the expression of phenotypic markers related to the neural lineage and myelination and decreased reactive gliosis and inflammation in the brain, increased neuronal survival in the peri-impact area of the cortex, and decreased inflammation in the spleen at 90 days post-TBI. These results provide evidence that high and moderate doses of ISC-hpNSC ameliorate TBI-associated histological alterations and motor, neurological, and cognitive deficits."

Journal

Novel Approach to Stem Cell Therapy in Parkinson's Disease. (PubMed, Stem Cells Dev) - P1; "The Australian regulatory agency Therapeutic Goods Administration (TGA) and the Melbourne Health's Human Research Ethics Committee (HREC) independently reviewed ISCO's extensive preclinical data and granted approval for the evaluation of a novel human parthenogenetic derived neural stem cell (NSC) line, ISC-hpNSC, in a PD phase 1 clinical trial ( ClinicalTrials.gov NCT02452723)...It is worth noting that ISCO underwent an exhaustive review process and successfully answered the very comprehensive, detailed and specific questions posed by the TGA and HREC. The regulatory/ethic review process is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines or novel therapies."

Journal

International Stem Cell Corporation Announces Operating Results for the Quarter Ended March 31, 2019 (GlobeNewswire, International Stem Cell Corporation) - "International Stem Cell Corporation...today provided a business update announcing operating results for the three months ended March 31, 2019....'In Q1 2019 we recently achieved a major milestone in the world's first approved human pluripotent stem cell-based clinical trial for the treatment of Parkinson's disease....In connection with the conclusion of the treatment phase of the study, we anticipate the clinical trial-related expenses to significantly decrease,' commented Andrey Semechkin, PhD., CEO and Co-Chairman of ISCO."

Commercial

International Stem Cell Corporation Completes Enrollment and Dosing in its Parkinson’s Disease Clinical Trial (GlobeNewswire, International Stem Cell Corporation) - "International Stem Cell Corporation...announced today the completion of subject enrollment in its phase 1 clinical trial of ISC-hpNSC® for the treatment of Parkinson’s disease. The fourth subject of the third cohort, who was the twelfth and final subject of the phase 1 clinical study, was successfully transplanted with the highest dose of ISC-hpNSC® cells....We expect to announce complete clinical results of this phase 1 clinical trial in the first half of 2020...Thus far there have been no serious adverse events related to the transplanted ISC-hpNSC®...Interim results of this study will be presented at the upcoming 2019 American Academy of Neurology 71st Annual Meeting in Philadelphia, PA on May 5th, 2019."

Enrollment status • P1 data

Results of an Open Label, Dose Escalating, Phase 1 Clinical Trial Evaluating the Safety of a Human Neural Stem Cell Based Therapy in Parkinson’s Disease (AAN 2019) - P1; "Interim results of the world’s first human pluripotent stem cell based therapy for PD show that transplantation of ISC-hpNSC is safe, well tolerated, and can potentially improve the quality of life of patients."

Clinical • P1 data

A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's Disease (clinicaltrials.gov) - P1; N=12; Active, not recruiting; Sponsor: Cyto Therapeutics Pty Limited; Recruiting ➔ Active, not recruiting

Enrollment closed

International Stem Cell Corporation Publishes Successful Results in Traumatic Brain Injury (GlobeNewswire, International Stem Cell Corporation) - The publication, titled, “Human parthenogenetic neural stem cell grafts promote multiple regenerative processes in a traumatic brain injury model,” demonstrated that the clinical-grade neural stem cells used in our Parkinson’s disease clinical trial, ISC-hpNSC®, significantly improve TBI-associated motor, neurological, and cognitive deficits without any safety issues. Rodents injected with moderate and high doses of ISC-hpNSC® significantly improved motor function, neurologic function, and cognition compared to the control animals receiving no treatment.

Preclinical