IMPORTANT MESSAGE

First ever transplantation of hematopoietic stem cells for diabetes mellitus (DM) was performed by Prof. O.I. Smikodub and his group on December 2, 1991 in the I Medical Department of Kiev Municipal Clinical Hospital No.4, Ukraine.

Hematopoietic stem cells (HSC) were isolated from the liver of 8 weeks old embryonic cadaver and transplanted to patient P. (born in 1960) four months after onset of the disease (type 1 diabetes mellitus).  In the following 3 months, insulin intake decreased by 55% and was maintained at this level for 9 months.  This discovery fostered clinical study of hematopoietic embryonic stem cells harvested from liver, spleen, and bone marrow of 5-8 weeks old embryonic cadavers in types 1 and 2 DM, in different clinical courses of DM and its complications.  The results were stunning: decrease of insulin intake by 30-70%, discontinuation of insulin therapy, decrease of the doses of oral antiglycemic medications, lower hyperinsulinism, normalization of endogenic insulin and C-peptide.

In his clinical trial, Prof. Smikodub was joined by the Academician of the Ukrainian Academy of Medical Sciences Prof. A.S. Yefimov and Candidate of Medical Sciences A.V. Novitskaya. 

The year of 1993 was marked by filing patent application in Ukraine with the priority date of October 18, 1993.  This date is confirmed by the patents of Ukraine, Russian Federation, Greece, and Netherlands.  There is a patent pending in USA.  

This group was the first in the world to propose medicinal formulation based on cryopreserved hematopoietic embryonic stem cells for types 1 and 2 DM. 

For her thesis Human Embryonic Liver Cells in Diabetes Mellitus Complicated by Immunological and Hematological Disorders A.V. Novitskaya was awarded a degree of the Candidate of Medical Sciences.

Patents granted:

1.  Patent #1002968, Greece

Industrial Property Organization

Medical Preparation Based on Fetal Cell Suspensions with Immune Correcting Effect and Method of Treatment of Diabetes Mellitus with the Use of Said Preparation /Efimov A.S., Novitskaya A.V., Smikodub A.I.

Date of issue: Sep. 9, 1998.

2.  Patent #2126260, Russia

Immune-Correcting Medicinal Formulation Based on Cell Suspensions and its Application in Diabetes Mellitus /Efimov A.S., Smikodub A.I., Novitskaya A.V.

 Date of issue: Feb.20, 1999.               

3. Patent #27048, Ukraine

Immune-Correcting Medicinal Formulation Based on Cell Suspensions and its Application in Diabetes Mellitus / Smikodub A.I., Efimov A.S., Novitskaya A.V.

      Date of issue: Feb.28, 2000.

4. Patent #194693, Netherlands

     Werkwijze voor het bereiden van medicinale preparaten voor het behandelen van diabetes

     Efimov A.S., Smikodub A.I., Novitskaya A.V.

     Date of issue: February 14, 2003.

Priority date: October 18, 1993

Our achievements in this field were published in the following releases:

1.      Smikodoub A.I., Novitskaya A.V., Yefimov A.S. Fetal Cell Suspensions in Diabetes Mellitus. Cell Transplantation. – 1999. – Vol.8, № 2. – Р. 200.

2.      Smikodub A.I. Hematopoietic Embryonic Liver Cells in New Onset Diabetes Mellitus. Endocrynology.* – Kyiv. -  2001. – Vol.6, № 1. - P. 80-88.

3.      Smikodub A.I. Correction of Anemia in Type 1 Diabetes Mellitus with Hematopoietic Cells of Human Embryonic Liver. Endocrynology. -  2002. - Vol.7, №1. - P. 42-47.

4.      Yefimov A.S., Smikodub A.I., Novitskaya A.V. Transplantation of Hematopoietic Cells of Human Embryonic Liver in Type 1 Diabetes Mellitus. Transplantology. – 2002. - Vol.3, №2. – P. 26-31.

5.      Novitskaya A.V., Smikodub A.I. Embryonic Cell Suspensions Containing Stem Cells in Type 1 Diabetes Mellitus. Transplantology. - 2003. – Vol. 4, №1. – P. 172-174.

6.      Smikodub A.I., Novitskaya A.V. Embryonic Stem Cells in New-onset Type 2 Diabetes Mellitus. Abstract Book. -  Dublin. - 2004. – P. 44.

7.      Smikodub A.I., Novitskaya A.V. Embryonic Stem Cells in Pernicious Decompensated Type 2 Diabetes Mellitus. Abstract Book. -  Dublin. - 2004. – P. 45.

8.      Smikodub A.I., Novitskaya A.V. Embryonic Stem Cells in Type 1 Diabetes Mellitus. Transplantology. -  2004. -  Vol.7.,  №3. – P. 360-363.  

9.      Smikodub A.I., Novitskaya A.V. Embryonic Stem Cells for Correction of Insulin Resistance in Type 2 Diabetes Melllitus Cells. Family Medicine. – 2004. - №3. – P. 136.

10. Smikodub A.I., Novitskaya A.V. Embryonic Cell Suspensions in Complicated Decompensated Type 2 Diabetes Mellitus. Cytotherapy. – Berlin. – 2006. - Vol. 8. – Suppl. 1. – P. 93.

11. Smikodub A.I. Embryonic Cell Suspensions in New-Onset Type 1 Diabetes Mellitus. Cytotherapy. – Berlin. - 2006 – Vol. 8. – Suppl. 1. – P. 94.

12. Smikodub A.I., Novitskaya A.V. Embryonic Cell Suspensions in New-Onset Type 2 Diabetes Mellitus. Abstract book. - Rotterdam. - 2006. – P. 39.

13. Smikodub A.I., Novitskaya A.V. Embryonic Cell Suspensions in New-Onset Type 1 Diabetes Mellitus. Abstract Book. - Rotterdam. -  2006. – P. 191.

14. Smikodub A.I., Novitskaya A.V. Embryonic Cell Suspensions in Complicated Decompensated Type 2 Diabetes Mellitus. Abstract Book. – Rotterdam. - 2006. – P. 192.

15. Smikodub A., Novitskaya A. Embryonic Cell Suspensions in New-Onset Type 1 Diabetes Mellitus. Diabetic Medicine. – Cape Town. - 2006. -  – Vol. 23, Suppl. 4. – P 663-664.

16. Smikodub A.I., Novytska A.V. Embryonic Stem Cells for Insulin Resistance Decrease in Patients with Impaired Glucose Tolerance. Diabetes & Vascular Disease Research (Official Journal of the International Society of Diabetes and Vascular Disease) – Barcelona. – 2007. – Vol.4, Suppl.1 – P.113-114.

Oral and poster presentations of our achievements in the field were presented at the following international conferences:

1.      10^th Annual Meeting of the International Society for Cellular Therapy meeting. Dublin, May 7-10, 2004.

2.      1^st International Congress on “Prediabetes” and the Metabolic Syndrome.  Berlin, Germany, April 13-16, 2005.

3.      Stem Cell Therapy Seminar for Medical Community of Malaysia.  Penang, Malaysia, November 2, 2005.

4.      12^th Annual Meeting of the Society for Cellular Therapy.  Berlin, Germany, May 4-7, 2006.

5.      Annual TERMIS-EU Meeting. Rotterdam, Holland, October 8-11, 2006.

6.  19^th World Diabetes Congress.  Cape Town, South Africa, December 3-7, 2006.

We drafted guidelines on clinical application of our methods that were adopted by the Bioethics Committee of the Cabinet of Ministers of Ukraine:

1.      Hematopoietic Embryonic Liver Cells in New Onset Insulin-Dependent Diabetes Mellitus/Guidelines.

     Authors: A. Yefimov, A. Smikodub, A., Novitskaya – Kyiv - 2000.

2.      Hematopoietic Embryonic Liver Cells in Anemia Caused by Insulin-Dependent Diabetes Mellitus/Guidelines.

Kyiv – 2002.

Our method is approved and implemented into daily clinical practice, and by now hundreds of patients had the opportunity to feel the effects of this highly beneficial and advanced therapy.