Taskin Bioregeneration Announces Launch of Phase II/III Clinical Trials for DesRep

Tehran, October 2024 – Taskin Bioregeneration, a pioneering company in regenerative medicine and cell therapy, is proud to announce the launch of Phase II/III clinical trials for DesRep, an advanced treatment specifically designed to address chronic wounds and diabetic foot ulcers. This trial comes after receiving ethical committee approval and will be conducted in collaboration with Tehran University of Medical Sciences and Jihad Branch of Tehran University. (https://irct.behdasht.gov.ir/trial/76789)

Diabetic foot ulcers (DFUs) represent one of the most serious and common complications of diabetes, affecting approximately 15% of diabetic patients globally. DFUs often lead to protracted healing times and are associated with a high risk of infection, amputation, and significant healthcare costs. Managing diabetic foot ulcers is a major healthcare challenge, with patients frequently experiencing treatment failures due to the disruption of the normal wound healing process, including delayed epithelialization, impaired angiogenesis, and inflammation.

In a Phase I clinical trial, DesRep—which combines DestroCell, allogenic placenta-derived stromal cells, and a hydrogel matrix—yielded remarkable outcomes in patients with diabetic foot ulcers. Chronic wounds, particularly those persisting for more than three months, are notoriously difficult to treat, but DesRep showed an impressive 80% reduction in wound size within a three-month treatment period for the group receiving the cell therapy.

The hydrogel in DesRep acts as a carrier, ensuring the stromal cells maintain viability and can proliferate and differentiate effectively. This, in turn, supports the immunomodulatory effects of DestroCell, which has shown the ability to reduce inflammation, stimulate new blood vessel formation (angiogenesis), and promote tissue repair. Histopathological assessments revealed the wounds treated with DesRep advanced to the epithelialization and granulation phases, with no severe inflammatory responses or cellular infiltration observed, underscoring its safety profile.

By contrast, the control group, which was treated with hydrogel alone, exhibited a more modest 50% reduction in wound size, and 20% of the wounds in this group remained in the pre-granulation stage, signaling a higher risk for future complications.

These results, combined with the lack of severe inflammation or adverse reactions, underscore DesRep’s potential as a groundbreaking therapy for diabetic foot ulcers and chronic wounds, which often resist conventional treatments.

About Taskin Bioregeneration

Taskin Bioregeneration is a leading company in the field of regenerative medicine and cell therapy, committed to developing cutting-edge therapies that address complex health challenges. The company’s mission is to leverage the therapeutic potential of cell-based therapies to provide innovative treatments for patients suffering from conditions like chronic wounds, autoimmune disorders, and cancer.

With a strong focus on research and development, Taskin Bioregeneration has collaborated with leading academic institutions and hospitals to bring advanced cell and gene therapies to market. By offering treatments like DestroCell, Taskin Bioregeneration aims to improve patient outcomes and revolutionize care for conditions with limited therapeutic options.

About DestroCell

DestroCell, Taskin Bioregeneration’s flagship product, is an allogenic stromal cell therapy derived from the placenta (decidua). These cells possess powerful immunomodulatory and angiogenic properties, making them highly effective in promoting tissue repair and modulating the immune response.

Beyond its application in wound healing, DestroCell has been approved by the Iran Food and Drug Administration (FDA) for the treatment of graft-versus-host disease (GvHD), a condition that occurs after stem cell transplants. In treating GvHD, DestroCell has shown considerable success in reducing inflammation and supporting the regeneration of damaged tissues.

As part of DesRep, DestroCell plays a critical role in managing chronic wounds. Its ability to regulate inflammation and promote new blood vessel formation helps restore the natural healing process, even in wounds that have remained open and unhealed for extended periods. Coupled with a hydrogel matrix that supports cell viability, DestroCell delivers targeted therapeutic effects to enhance wound closure and prevent recurrence.

Prevalence and Challenges of Diabetic Foot Ulcers

Diabetic foot ulcers are a major global health concern, particularly in countries where the incidence of diabetes is rising. These wounds account for a significant portion of diabetes-related hospital admissions and are often precursors to severe complications such as infections and amputations. In many cases, DFUs do not heal properly due to impaired blood flow, immune dysfunction, and chronic inflammation. As a result, patients with diabetic foot ulcers face a higher risk of limb loss, reduced quality of life, and increased healthcare costs.

Looking Ahead

Taskin Bioregeneration’s Phase II/III clinical trials for DesRep will further evaluate the efficacy and safety of this innovative treatment on a larger patient population. These trials will mark a significant step forward in the fight against chronic wounds, bringing DesRep closer to becoming a widely accessible therapy for patients who suffer from diabetic foot ulcers.

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