The U.S. Food and Drug Administration (FDA) has announced the historic approval of Ryoncil (remestemcel-L-rknd) as the first mesenchymal stromal cell (MSC) therapy for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in children aged two months and older. This breakthrough marks a transformative moment in the treatment of GVHD, a life-threatening condition faced by patients undergoing stem cell or bone marrow transplants.
SR-aGVHD occurs when donor immune cells attack the recipient’s tissues, and current treatments, like high-dose steroids, often fail to manage this severe complication. The FDA’s decision is based on a pivotal phase 3 clinical trial demonstrating Ryoncil’s remarkable efficacy, with an overall response rate (ORR) of 70% at 28 days, including a 30% complete response rate.
Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research, emphasized:
“This approval highlights the potential of innovative cell-based therapies to address life-threatening diseases. It’s a significant step forward for patients, especially children, who have had limited options.”
Ryoncil’s approval validates the therapeutic potential of MSCs derived from bone marrow. These cells excel in immune regulation and inflammation control, offering a novel mechanism to manage GVHD and potentially other inflammatory conditions.
Taskin Bioregeneration: A Leader in MSC-Based Therapies
At Taskin Bioregeneration, we are thrilled by this global recognition of MSC therapy’s efficacy, which aligns closely with our own innovations in cell therapy. Our flagship product, DestroCell, is derived from allogenic placenta (decidua) stromal cells and has already demonstrated significant potential in treating inflammatory and autoimmune conditions, including GVHD.
DestroCell is unique in its ability to modulate immune responses and promote angiogenesis, making it an ideal candidate for treating complex conditions like GVHD. In fact, DestroCell received Iran FDA approval as the first MSC-based therapy included in the Iranian Drug List (IDL) for SR-aGVHD and other autoimmune diseases.
The FDA’s recent approval of Ryoncil underscores the transformative power of MSCs, affirming our approach and further validating the therapeutic potential of DestroCell. This milestone reinforces our commitment to expanding the accessibility of cutting-edge cell therapies globally.
We are inspired by this success and remain focused on advancing cell-based treatments that improve patient outcomes.