Study of iPSC-Derived Motor Neuron Precursor Cell Therapy for Adults Aged 18 to 60 with ALS

What this Trial Is About

Amyotrophic lateral sclerosis ALS is a serious disease affecting the motor system, involving damage to nerve cells that control movement. Researchers are exploring the use of induced pluripotent stem cells iPSCs, which can develop into motor neuron precursor cells, as a potential treatment for ALS. This trial aims to evaluate the safety of human iPSC-derived motor neuron precursor cells in people with ALS, addressing the urgent need for new therapies. This open-label clinical trial includes three phases a 7-day baseline period, a 45-day treatment period, and a 6-month follow-up. During treatment, participants will have a drug pouch surgically implanted, through which they will receive four doses of stem cell injections every two weeks. Each dose consists of 50 million motor neuron precursor cells delivered through the pouch. The trial includes close monitoring for adverse events and assessments using various clinical scales and tests. Participants will undergo detailed assessments before surgery, including physical exams, laboratory tests, and cognitive and mood evaluations. During treatment, vital signs and safety labs will be regularly checked, along with self-assessments using ALS-specific scales. Follow-up visits occur at 1, 3, and 6 months after completing treatment to monitor safety and effectiveness. The study focuses on recording adverse events and evaluating physical function and neurological health over time.

Clinical Study of Induced Pluripotent Stem Cells Derived Motor Neuron Precursor Cell Therapy for Amyotrophic Lateral Sclerosis (ALS)