The Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis

General Information

Summary A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects with Amyotrophic Lateral Sclerosis
Clinical trials phase Phase 1
Start date (estimated) 2025-08-04
End date (estimated) 2028-09-30
Clinical feature
Label amyotrophic lateral sclerosis
Link http://purl.obolibrary.org/obo/DOID_332
Description A motor neuron disease that is characterized by muscle spasticity, rapidly progressive weakness due to muscle atrophy, difficulty in speaking, swallowing, and breathing.

Administrative Information

NCT number NCT07118319
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT07118319
Other study identifiers
Name XS228-Allo-ALS-CN1/2-P01
Study sites
Sponsors XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.

Cells

Which differentiated cell type is used
Label motor neuron
Link http://purl.obolibrary.org/obo/CL_0000100
Description An efferent neuron that passes from the central nervous system or a ganglion toward or to a muscle and conducts an impulse that causes or inhibits movement.; Motor neurons, also known as motoneurons, are a type of neural cell that is fundamental to voluntary movement of muscles. Located within the central nervous system (CNS), motor neurons in the motor cortex travel to the brainstem and spinal cord. Motor neurons in the brainstem and spinal cord extend their lengthy axons out to muscles throughout the body. These specialized neurons are an inherent part of the so-called somatic division of the nervous system which mediates conscious control of skeletal muscles. The primary function of motor neurons is to relay signals from the CNS to the body's many muscles, controlling both their contraction and relaxation. In response to impulses transmitted from the brain or spinal cord, it creates an electrical signal (action potential), which travels along its axon to cause the controlled movement of specific muscles. Motor neurons can connect with skeletal muscles, cardiac muscles, or glands, leading to three respective types: somatic motor neurons, autonomic motor neurons, and the neurons of the enteric nervous system. Key components of motor neurons include the cell body (soma), dendrites, and axons. The cell body houses the nucleus and is the site of the neuron's intrinsic functions. Dendrites are thin structures that branch from the cell body and receive messages (electrical signals) from other neurons. The axon, a long, single tail-like extension, carries these signals away from the cell body towards the targeted muscle. If a motor neuron is damaged or dies, the muscle or gland it controls can lose function, which can result in conditions like motor neuron disease, leading to muscle weakness and atrophy. (This extended description was generated by ChatGPT and reviewed by the CellGuide team, who added references, and by the CL editors, who approved it for inclusion in CL. It may contain information that applies only to some subtypes and species, and so should not be considered definitional.)

Recruitment

Recruitment Status Not yet recruiting
Estimated number of participants 12
Contact institutions/departments