Mesenchymal stem cells therapy (Therapeutic Solutions International)
- Generic Name
- Mesenchymal stem cells therapy (Therapeutic Solutions International)
FDA Clears Brainstorm Cell Therapeutics' Phase 3b Trial of NurOwn for ALS Treatment
• Brainstorm Cell Therapeutics has received FDA clearance to initiate a Phase 3b trial of NurOwn for the treatment of Amyotrophic Lateral Sclerosis (ALS), marking a significant advancement in their clinical development program.
• The company's proprietary NurOwn technology utilizes Mesenchymal Stem Cells (MSC) that are differentiated into neurotrophic factor-secreting cells and transplanted near damaged areas, offering a novel approach to treating neurodegenerative diseases.
• Following the FDA announcement, Brainstorm's stock surged by 31.82% in premarket trading, reflecting strong investor confidence in the potential of this stem cell therapy for ALS patients.
Abu Dhabi Successfully Completes First Stem Cell Trial for Knee Osteoarthritis with Promising Results
• The Department of Health – Abu Dhabi has completed a groundbreaking Phase I/II clinical trial of StromaForte, a mesenchymal stem cell therapy for knee osteoarthritis, demonstrating a favorable safety profile with no serious adverse events.
• Patients receiving the single 50-million cell injection reported significant pain reduction as measured by Visual Analogue Scale (VAS) and improved quality of life, suggesting potential as a non-surgical alternative for degenerative joint disease.
• The trial, conducted from November 2023 to October 2024 in collaboration with Swedish biotech Cellcolabs and Burjeel Holdings, represents a significant advancement in cell-based therapies with detailed MRI findings to be presented at Abu Dhabi Global Health Week in April 2025.
Longeveron's Laromestrocel Shows Promise in Phase 2a Trial for Mild Alzheimer's Disease
• Longeveron's Phase 2a CLEAR MIND trial demonstrated that laromestrocel (formerly Lomecel-B) is safe and well-tolerated in patients with mild Alzheimer's disease, with no reported cases of amyloid-related imaging abnormalities.
• The cellular therapy showed statistically significant improvements in cognitive function measured by the Montreal Cognitive Assessment, daily living activities, and preservation of brain volume compared to placebo.
• Laromestrocel has received both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA, positioning it as potentially the first cellular therapeutic for Alzheimer's disease.
FDA Grants Fast Track Status to BRTX-100 for Chronic Lumbar Disc Disease Treatment
• BioRestorative Therapies receives FDA Fast Track designation for BRTX-100, accelerating the development pathway for their chronic lumbar disc disease treatment program.
• The Fast Track status highlights the significant unmet medical need in chronic lumbar disc disease treatment and potential of BRTX-100 to address this condition.
• This regulatory milestone enables more frequent FDA interactions and potential eligibility for priority review, potentially expediting the therapy's path to market.
BioCardia Completes Low-Dose Cohort Enrollment in Novel CardiALLO Trial for Heart Failure Treatment
• BioCardia has completed enrollment and dosing of the low-dose cohort in its CardiALLO Phase I/II trial, targeting ischemic heart failure patients with elevated markers of heart stress and inflammation.
• The groundbreaking trial utilizes allogeneic mesenchymal stem cells delivered through BioCardia's minimally invasive system, with the first Data Safety Monitoring Board review expected in March 2025.
• The study incorporates precision medicine approaches and FDA-approved Morph DNA steerable guide technology, aiming to enhance therapeutic delivery and patient outcomes in heart failure treatment.
Adipose-Derived Stem Cell Injections Show Promise in Treating Inflammatory Eye Diseases
• Japanese researchers demonstrate that local injections of adipose-derived mesenchymal stem cells effectively reduce inflammation in ocular graft-versus-host disease, offering a safer alternative to corticosteroids.
• The study reveals that stem cell treatment increases regulatory T cells and enhances tissue healing, with injected cells naturally clearing within a week, minimizing long-term complications.
• Researchers at Fujita Health University report successful localized therapy effects in mouse models, setting the stage for potential human clinical trials of this targeted treatment approach.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2025. All Rights Reserved by MedPath