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VAS-101: A Significant Advancement in Red Blood Cell Preservation

The latest research into the preservation of stored red blood cells has unveiled promising results concerning VAS-101, a product developed by Vascarta Inc. This breakthrough comes from collaborative studies conducted by the FDA's Laboratory of Biochemistry and Vascular Biology, alongside researchers from the University of California in San Diego and Albert Einstein College of Medicine.

Stored red blood cells are subject to biochemical and structural changes over time, referred to as storage lesions. These lesions can adversely affect the safety, therapeutic efficacy, and overall lifespan of the cells once they are transfused into patients. Recognizing the need for improvement, scientists explored ways to mitigate these changes.

The Role of Curcumin in VAS-101

Initial studies indicated that adding a specific biocompatible gel based on curcumin—a compound known for its anti-inflammatory and antioxidant properties—could address these issues. VAS-101, which contains this concentrated curcumin gel, was developed for its ability to deliver therapeutic benefits through the skin. The active ingredient, Curcugen®, has been recognized for its potential to rejuvenate stored red blood cells.

In a groundbreaking study published in Scientific Reports, researchers documented that administering VAS-101 to stored red blood cells led to a remarkable reduction in oxidative damage by nearly 50%. Furthermore, ATP levels, essential for red blood cell functionality, increased by approximately 40%. This enhancement in ATP levels suggests that treated cells are better equipped to support vascular health.

Enhancements in Storage and Circulation

The implications of these findings are substantial. Particularly, the study established that VAS-101-treated red blood cells could extend their refrigerated storage period by an additional week. Importantly, animal model testing revealed that these treated red blood cells had a 10% longer survival rate compared to untreated counterparts when transfused into guinea pigs, which serve as a validated surrogate for human circulatory systems.

Future Potential and Clinical Testing

The promising outcomes indicate a clear potential for using VAS-101 to enhance the properties of stored red blood cells. Expectations include not only extended storage times but also improved safety and efficacy upon transfusion. Dr. Joel Friedman, a notable figure in the study, stated that these findings highlight VAS-101's potential as a rejuvenating additive, advocating for its future use in biopreservation.

Vascarta's CEO, Dr. Richard Prince, emphasized the significance of these results and expressed a commitment to prioritize human clinical trials involving Vasceptor® in the treatment of sickle cell disease, set to commence in early 2025.

Regulatory Context and Company Profile

The research aligns with the FDA's commitment to facilitating innovations in biological products for human use, ensuring that therapies are both safe and effective. Vascarta, as a startup in the pharmaceutical industry, aims to take advantage of transdermal drug delivery methods to address various medical conditions including arthritis, hypertension, and cancer.

For patients across 22 states, VAS-101 is currently available via prescription at licensed compounding pharmacies, signifying a tangible step towards real-world application of this innovative treatment. As more data emerges from ongoing studies, the anticipation continues to grow around the impact of VAS-101 on transfusion medicine and red blood cell biopreservation.