Chinese stem cell (iPSC) therapies receive Phase I trial clearance for ALS & Parkinson’s

China’s Xellsmart Biopharmaceutical announced that the FDA has approved its Investigational New Drug (IND) application to begin a Phase 1 clinical trial of XS-228, a stem cell-based therapy candidate for amyotrophic lateral sclerosis (ALS).

This approval follows early clinical studies conducted last year in China. According to the company, XS-228 is the first experimental therapy of its type (induced-pluripotent stem cell/iPSC) for ALS to reach this clinical stage.

The FDA previously granted XS-228 orphan drug designation, a status intended to accelerate the development of treatments for rare conditions.

Additionally, the FDA has cleared Xellsmart to initiate a Phase 1 clinical trial for XS-411, the company’s cell therapy candidate targeting Parkinson’s disease.

ALS is characterized by the progressive dysfunction and death of motor neurons (nerve cells responsible for voluntary muscle control). As motor neurons deteriorate, individuals experience symptoms such as muscle weakness and paralysis, eventually leading to respiratory failure.

Currently approved ALS treatments primarily focus on managing symptoms rather than addressing the underlying causes of neuronal loss. Stem cell-based therapies like XS-228 aim to replace damaged or lost nerve cells, potentially slowing or reversing disease progression.

XS-228 uses induced pluripotent stem cells (iPSCs), adult-derived cells that are reprogrammed in a laboratory setting into an embryonic-like state. These cells are capable of developing into different specialized cell types. In the case of XS-228, these iPSCs are matured into motor neuron precursor cells before transplantation into patients’ brains. Once transplanted, these precursor cells are intended to integrate into existing neural circuits and restore impaired neural function.

According to the company, they’re using allogeneic iPSCs, which allows them to manufacture XS-228 in higher quantities and store for later use, potentially giving clinicians rapid accessibility and more consistent quality (as opposed to autologous iPSC manufacturing).

The company says that their early-stages in China demonstrated safety and suggested that it slows the progression of ALS compared to standard treatment.

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