Strong pipeline of stem-cell based products for neurology indications, says GlobalData

Despite several theoretical applications and benefits associated with them, the development of stem-cell based therapies has been slow. However, as regulatory framework becomes more established and more pipeline products enter clinical trials, leading data and analytics company GlobalData foresees a wider ecosystem with more stem-cell based products.

 Vinie Varkey, MSc, Healthcare Senior Analyst at GlobalData, says: “Inherent variation within the human cell population poses process validation challenges, and the lack of a clear and harmonized regulatory framework on stem cell treatments also poses a challenge to development in this area. All of these factors contribute to a long development timeline and associated developmental costs.” 

Varkey concludes: “As the regulations become clearer and more pipeline products enter clinical trials, the US FDA’s recently announced regulatory developments will help to establish a wider ecosystem that will help to clarify the approval process of safe stem-cell based products.” 

According to GlobalData, The current pipeline consists of 16 products (Phase 1,2, and 3), and the most common indications for which these products are being evaluated include Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s Disease and Parkinson’s Disease. The most commonly understood mechanism of action underlying stem cells therapy in neurology is the potential ability of these therapies to secrete trophic factors that help in neuronal survival and growth. As research in this field progresses, it is expected to help further improve the understanding of how these therapies work and, potentially address unmet needs in the field of neurology.