Waisenmedizin e.V. Germany is currently developing LeiProtect® (liquid wound dressing) as a medical device and has special approval from the BfArM for LeiProtect® to treat wounds caused by cutaneous leishmaniasis in Germany. LeiProtect® is a liquid wound dressing that hardens on the wound, creating a protective film.
What is so special about LeiProtect®?
LeiProtect was developed in collaboration with Prof. em. Dr. Kurt Bauer, the former chair of pharmaceutical technology at the University of Freiburg. Prof. Bauer also worked in the pharmaceutical industry for a long time.
The focus of development was on application to patients. These often live in poor hygienic conditions, which is why LeiProtect® is autosterile and can easily be filled from a 1 liter storage container via an adapter directly into a standard small syringe without contact with the outside world. The patient is usually given a few ml, which is sufficient for 7 days of treatment.
The results of the clinical studies are listed here.
Why does LeiProtect® need CE certification?
Even underdeveloped countries do not allow the import of medical devices without a certificate from an internationally recognized authority. Therefore, the Orphan Medicine Association must carry out the CE certification that applies in Europe.
Since 2020 we have been led by Dr. from Martius, – Medical Technology Consultant – to advance the CE certification.
Where is LeiProtect® manufactured?
LeiProtect® was manufactured by the clinical pharmacy in Erlangen. We have now found a certified manufacturer of medical devices who will produce LeiProtect® for our association from 2023. The mixer donated to us by the Ystral company for bubble-free mixing of the gel is also used by the new manufacturer.
What is LeiProtect®made of?
With the exception of one substance, the materials used in the LeiProtect® formulation are available in pharmaceutical quality.
Prof. Philipp Kurz’s working group in the Chemical Institute at the University of Freiburg helped us a lot with the difficult purification of the material, which is only available as a technical quality. In particular, Semra Genc, who is doing her doctorate under Prof. Kurz, has significantly increased its purity. Based on a colloquium in 10/2019, the AKKU (Kurz working group) dealt intensively with the underlying chemical aspects. Our NGO is extremely grateful for this.
What does a Leishmainia wound look like and how does the healing process progress?
Can LeiProtect heal Leishmania wounds faster than usual remedies?
Our NGO was able to prove this in several clinical studies. The two most important ones are listed below.
Klinische Phase II Studie Nr. 1
Jebran, A. F., Schleicher, U., Steiner, R., Wentker, P., Mahfuz, F., Stahl, H.-C., Amin, F. M., Bogdan, C., & Stahl, K.-W. (2014). Rapid Healing of Cutaneous Leishmaniasis by High-Frequency Electrocauterization and Hydrogel Wound Care with or without DAC N-055: A Randomized Controlled Phase IIa Trial in Kabul. PLoS Neglected Tropical Diseases, 8(2), e2694.
Klinische Phase II Studie Nr. 2
Stahl, H. C., Ahmadi, F., Schleicher, U., Sauerborn, R., Bermejo, J. L., Amirih, M. L., Sakhayee, I., Bogdan, C., & Stahl, K. W. (2014). A randomized controlled phase IIb wound healing trial of cutaneous leishmaniasis ulcers with 0.045% pharmaceutical chlorite (DAC N-055) with and without bipolar high frequency electro-cauterization versus intralesional antimony in Afghanistan. BMC Infectious Diseases, 14(1), 1–12. https://doi.org/10.1186/s12879-014-0619-8