Effectiveness of Exosomes to Be Scientifically Evaluated for the First Time Worldwide

STEMBIO Stem Cell Technologies and Koç Healthcare have launched a multicentre clinical study in collaboration to evaluate the clinical use potential of umbilical cord-derived mesenchymal stem cell exosomes in chronic wound treatment. The research will seek new biotechnological solutions for chronic wounds and diabetic foot ulcers affecting millions of people in Turkey.

In recent years, exosomes have shown promise in many areas of medicine, but there is as yet no licensed treatment option. For the first time, a clinical study aims to scientifically evaluate the efficacy and safety data of exosomes.

The study, launched across 12 healthcare centres in different regions of Turkey, plans to administer a total of 500 doses of exosomes under ethics board approval by 13 specialist doctors to voluntary patients who have completed the informed consent process.

"A scientific beginning that will contribute to biotechnological progress"
The project launch meeting was held at RMK AIMES (Academy of Interventional Medicine, Education and Simulation) within Koç University Hospital. The meeting was attended by doctors involved in the study as well as representatives of relevant institutions. At the meeting, it was announced that the research, conducted in collaboration between STEMBIO Stem Cell Technologies and Koç Healthcare, will be carried out within the framework of relevant legislation and under the supervision of ethics boards, and that scientific findings will be shared with the scientific community once obtained.

Koç Healthcare CEO Dr. Erhan Bulutcu said in his remarks at the meeting, recalling Koç Healthcare's pioneering role in innovation, biotechnology and research: "The strong R&D infrastructure we have at Koç Healthcare and the interdisciplinary collaborations we have established create the groundwork for developing innovative solutions in the biotechnology field. We see this study as a scientific beginning that will contribute to the widespread adoption of biotechnological approaches in our country. Biotechnological solutions not only facilitate access to treatment, but also enable improved quality of life for patients by offering personalized treatment approaches. As a group, we will continue to support investments in healthcare through similar studies and research."

Biotechnology offers hope for diabetic foot ulcers
Dr. Ali İmran Daştan from STEMBIO Stem Cell Technologies, one of the project leaders, shared: "The research will be conducted on people with chronic diabetic foot ulcers. There are 9.6 million diabetic adults in Turkey. Diabetic foot ulcers are generally chronic problems that take a long time to treat and seriously affect quality of life. Over the next 12 months, we aim to administer a total of 500 doses of exosomes to more than 100 patients with chronic diabetic foot ulcers. We hope that this study, to be conducted at centres selected from different provinces of Turkey, will provide an innovative solution to the treatment of foot ulcers, one of the most challenging complications of diabetes."

Economic burden of chronic wounds reaches USD 80 billion
Dr. Daştan, pointing out that labour losses due to untreated chronic wounds are measured in billions of dollars, continued: "According to analyses conducted globally, chronic wounds and related limb loss are projected to result in approximately USD 80 billion in economic burden and labour loss worldwide annually, and approximately USD 260 million in Turkey. Additionally, the global market size for the use of biological products in wound treatment is known to be approximately USD 3.4 billion."

Expert names will lead the project
Dr. Ali İmran Daştan from STEMBIO Stem Cell Technologies will lead the project, while Business Development Manager Özgür Kaplan is responsible for the clinical treatment follow-up programme, and Prof. Dr. Kerim Bora Yılmaz from the SBÜ Gulhane Training and Research Hospital manages the clinical process.

The researcher team conducting clinical applications in the study includes Dr. Alper Erkin, Dr. Alper Şener, Dr. Bengüsü Mirasoğlu, Dr. Bülent Ertuğrul, Dr. Emre Özker, Dr. Güneş Esendağlı, Dr. Kemal Korkmaz, Dr. Kerim Bora Yılmaz, Dr. Lercan Aslan, Dr. Murat Kendirci, Dr. Perçin Karakol, Dr. Rıza Aytaç Çetinkaya and Dr. Semih Bağhaki.