The value of an idea lies in the using of it ~ Thomas Edison
After completing the preclinical validation phase, REMAST therapy enters in the clinical path.
Hemera’s goal is to start the Clinical Trial in 2025.
To this end, Hemera’s scientists will work to address two main fronts: the production of the cell therapy according to the high pharmaceutical quality standards and the approval of protocols for the first applications of the therapy in humans.
In the first half of 2023, a prospective observational study of patients with complete traumatic spinal cord injury will begin.
The aims of the study are to monitor the clinical trend of motor, sensory and physiological functions in spinal cord-injured patients, starting from the acute post-traumatic phase, and to validate the criteria for inclusion of patients in the subsequent interventional study.
We are working to define the pharmacological grade production protocols of Hemera’s advanced cell therapy according to standardized criteria of safety, quality, efficacy, and reproducibility, required by Regulatory Agencies for the clinical use of drugs in humans.
In 2025, the multicenter Phase 1-2 trial will begin.
The objectives of the study are to demonstrate the safety and efficacy of REMAST therapy in humans, determine the optimal dose and validate the route of administration.
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