De En Es It
16 YEARS OF INTERNATIONAL CLINICAL EXPERIENCE IN TRANSPLANTATION OF HUMAN EMBRYONIC/FETAL STEM CELLS. REVIEW
THE WORLDS LARGEST CLINICAL EXPERIENCE IN EMBRYONIC STEM CELL TRANSPLANTATION FOR VARIOUS DISEASES AND CONDITIONS

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Clinical Trials

First revealed juvenile insulin dependant diabetes mellitus (type 1)

Embryonic Tissues Center "EmCell" under scientific guidance of Professor Alexander Smikodub has developed an Embryonic Stem Cell Transplantation - based method for treatment of Diabetes Mellitus.

The method posesses a unique set of curative effects:

- Decrease in the level of glycemia in patients suffering from initially revealed insulin-dependent diabetes mellitus.

- Early posttransplantation improvement of general state

- Amelioration of psycho physiological condition

- Restoration of immune indices

- Restoration of hemopoiesis

- Mitigation of dystrophy disorders and lesions

This method has proven its effectiveness in cases of diabetes types I and II.

The method is not related to transplantation of pancreas b-cells.

The most beneficial this method is in cases of first revealed insulin dependant Diabetes Mellitus (type 1). In the cases of immediate application of Embryonic Stem Cell Transplantation after debut of the disease some of such patients can completely abandon the use of external insulin.

We suggest to start clinical trials of Embryonic Stem Cell Transplantation in Diabetes Mellitus from the group of patients with recently revealed insulin dependant Diabetes Mellitus (type 1) who have the best chances to recover from Diabetes Mellitus or at least to diminish suffering from this disease more than other groups of Diabetes Mellitus patients.

Clinical objectives:

- Interruption or substantial retardation of Diabetes Mellitus progress in the cases of first revealed juvenile Diabetes type 1,

- Restoration to certain extent of own production of insulin,

- Decrease of external insulin dose demanded in each case,

- Improvement of life prognosis of the patients.

According to out experience (A.Smikodub, A.Novitskaya 1993-2000) the decrease of the demand for external insulin in such cases may be quite universal criteria of curative effect of Embryonic Stem Cell Transplantation.

In 100 % cases, after Transplantation the dosage of administered insulin was gradually decreased during 2 to 3 months.

The average initial dosage of insulin was 0.76+0.06 units/kg/day. Maximum decrease amounts to 20-100 % of the initial dosage (41% on the average), the term of this maximum decrease ranging within 14 to 90 days (59.0+4.3 days on the average). In 65 % cases, clinical remission of disease was developed (daily dosage of exogenous insulin being less than 0.4 units/kg/day or total cancellation of insulin therapy). Duration of remission is within 5 to 14 months.

From our point of view, due arrangement of immediate treating in cases of first revealed insulin dependant Diabetes Mellitus by means of Embryonic Stem Cell Transplantation according to the elaborated method can lead to even more significant results. We believe that in modern medicine there exists no peer to Embryonic Stem Cell Transplantation for such cases of Diabetes Mellitus treatment.

Table: Dynamics of daily insulin dosage (unit/kg/day) in patients suffering from recently revealed insulin dependent Diabetes Mellitus. Group treated by means of Embryonic Stem Cells Transplantation

Terms of observation Number of
patients
Mean
(unit/kg/day)
m
(St.err)
P
(P<0.05)
Period 1 Before treatment > 20 0.76 0.06  
2 Days
after
treatment
1-7 20 0.74 0.06 0.85
3 7-14 20 0.68 0.05 0.37
4 14-28 20 0.60 0.05 0.06
5 28-45 20 0.53 0.05 0.01*
6 45-60 20 0.46 0.05 0.00*
7 60-90 20 0.45 0.06 0.00*
8 90-180 20 0.47 0.05 0.00*
9 180-270 19 0.51 0.05 0.00*
10 270-365 15 0.57 0.05 0.03*
11 Years
after
treatment
2 9 0.58 0.03 0.06
12 3 6 0.59 0.03 0.13
13 4 5 0.60 0.03 0.20

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News
2008-09-25
Prof. Alexander I. Smikodub attended European Congress on Anti-Aging and

Prof. Alexander I. Smikodub attended European Congress on Anti-Aging and Aesthetic Medicine held in Dusseldorf, Germany on September 11-14, 2008 as ...
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Publications

25. Summary 2007

Participation in National and International Congresses, Conferences and Meetings III National Congress on Bioethics. Kyiv, Ukraine, October 8 – 11, 2007. IV Meeting of Transplantologists of Ukraine. ...
  Publications in English (1996-2003)
 
Patents

Medicinal preparation based on fetal cell suspension having immune substituting effect for patients with acquired immune ...
 
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