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We have developed an Embryonic Stem Cells Transplantation-based method (without pancreatic beta-cells) for treatment of diabetes mellitus. This method has proven its effectiveness in cases of diabetes types I and II. It is protected by a number of patents.
Protected by GREECE PATENT No 1002968,
RUSSUAN PATENT No 2126260...
Other patents pending.
Major effects of Embryonic Stem Cells Transplantation in patients with diabetes mellitus
Case reports
Tables
Embryonic Stem Cells Transplantation is indicated at all stages of diabetes; it is however the most effective in the cases of:
recently revealed insulin-dependent diabetes mellitus; diabetes mellitus complicated by diabetic glomerulosclerosis, chronic renal failure (grade 1 and 2) and anemic syndrome; labile course of diabetes mellitus; diabetes mellitus associated with infection complications and decrease of immune activity; presence of resistant to treatment trophic ulcers of soft tissues; secondary sulfanilamide resistance and the need for patients with diabetes mellitus type II to transfer to insulin therapy.
Major effects of Embryonic Stem Cells Transplantation:
Decrease of glycemia in patients with recently revealed insulin-dependent diabetes mellitus. Early posttransplantation improvement of general condition Improvement of psychophysiological condition Immunological reconstitution Reconstitution of hematopoiesis Improvement of dystrophy disorders and lesions
Decrease of glycemia in patients with recently revealed insulin-dependent diabetes mellitus.
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 duration of this maximum decrease ranging within 14 to 90 day (59.0+4.3 days on the average). In 65% cases, clinical remission was achieved (daily dosage of exogenous insulin being less than 0.4 units/kg/day or total discontinuation of insulin therapy). Duration of remission is from 5 to 14 months
Early posttransplantation improvement of general condition
Syndrome of the early posttransplantation improvement of general condition, consisting in a decrease of weakness, restoration of ability to work, appetite and sleep in 63 % cases. This reaction is manifested on the first day after Transplantation; it is clearly expressed during a month, following which this manifestation is somewhat reduced and is maintained during 2 to 4 month.
Improvement of psychophysiological condition
Syndrome of psychophysiological changes, consisting in the improvement of thinking and intellectual capabilities, muscular status, disappearance of fear etc. The above syndrome has been noted in 48 % cases; it lasts for 6 to 8 months.
Immunological reconstitution
Restoration of immunological parameters: increase of lymphocytes count, T-lymphocytes and subpopulations of T-lymphocytes. Average decrease of B-lymphocytes is 30 to 60%. The duration of this phenomenon vary from 3 to 8 months.
Reconstitution of hematopoiesis
Restoration of hematopoiesis in patients with diabetic glomerulosclerosis complicated by chronic renal failure (1 and 2 degrees), and anemic syndrome. Reliable increase of erythrocytes count and hemoglobin after 1 to 1.5 months. Duration of effect within 2 to 11 months.
Improvement of dystrophic disorders
Disappearance of trophic ulcers, improvement of skin lipidosis, diabetic foot, infectious and mycotic skin lesions, cutaneus lychenisation, lipoatrophic lesions.
Changes of daily insulin dosage (unit/kg/day) in patients with recently revealed insulin-dependent diabetes mellitus. Group treated with Embryonic Stem Cells Transplantation
Terms of observation |
Number of patients |
Mean (unit/kg/day) |
m (st.err) |
P (P<0.05) |
 |
1 |
Before the treatment |
20 |
0.76 |
0.06 |
|
2 |
|
Days |
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 |
Months |
1 - 11/2 |
20 |
0.53 |
0.05 |
0.01* |
6 |
11/2 - 2 |
20 |
0.46 |
0.05 |
0.00* |
7 |
2 - 3 |
20 |
0.45 |
0.06 |
0.00* |
8 |
3 - 6 |
20 |
0.47 |
0.05 |
0.00* |
9 |
6 - 9 |
19 |
0.51 |
0.05 |
0.00* |
10 |
9 - 12 |
15 |
0.57 |
0.05 |
0.03* |
11 |
Years |
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 |
Letter from our Patient
Chandes of immunological parameters in patients with recently revealed insulin-dependent diabetes mellitus
Parameters |
Normal rates |
Before treatment |
Periods of observation, after treatment (days) |
28 - 45 |
60 - 90 |
N=11 |
N=11 |
N=10 |
| M |
m |
M |
m |
p |
M |
m |
p |
| Lymphocytes, 109/l |
0.72-2.67 |
1.228 |
0.112 |
1.644 |
0.091 |
0.010* |
1.441 |
0.092 |
0.165 |
| T-lymphocytes (CD3+), 109/l |
0.701-2.005 |
0.777 |
0.066 |
1.129 |
0.070 |
0.002* |
0.965 |
0.061 |
0.052* |
| (CD3+), % |
68-82 |
64.0 |
2.2 |
68.8 |
2.2 |
0.151 |
68.2 |
1.6 |
0.169 |
| T-helpers (CD4+), 109/l |
0.357-1.254 |
0.429 |
0.052 |
0.586 |
0.053 |
0.048* |
0.535 |
0.036 |
0.119 |
| (CD3+), % |
29-55 |
34.6 |
1.9 |
35.5 |
2.0 |
0.731 |
36.8 |
2.7 |
0.499 |
| T-suppressors (CD8+), 109/l |
0.146-0.81 |
0.300 |
0.022 |
0.489 |
0.041 |
0.001* |
0.434 |
0.042 |
0.010* |
| (CD8+), % |
20-36 |
25.8 |
2.4 |
29.6 |
1.4 |
0.201 |
30.1 |
1.5 |
0.162 |
| T-helpers/T-suppressors, (CD4+/CD8+) |
1.1-2.2 |
1.50 |
0.18 |
1.22 |
0.07 |
0.182 |
1.26 |
0.12 |
0.312 |
| B-lymphocytes (CD19+), 109/l |
0.022-0.53 |
0.193 |
0.026 |
0.151 |
0.013 |
0.178 |
0.115 |
0.017 |
0.026* |
| (CD19+), % |
5-15 |
15.4 |
1.2 |
9.1 |
0.6 |
0.000* |
8.6 |
0.9 |
0.000* |
Changes of immunological parameters in patients with diabetic glomerulosclerosis, chronic renal failure grade 1
Indices |
Normal range |
Before treatment |
Period of observation (days) |
28-45 |
45-90 |
N=5 |
N=5 |
N=5 |
| M |
m |
M |
m |
p |
M |
m |
p |
| Lymphocytes, 109/l |
0.72-2.67 |
1.165 |
0.102 |
1.754 |
0.062 |
0.001 |
1.751 |
0.092 |
0.002 |
| T-lymphocytes, (CD3+) 109/l |
0.701-2.005 |
0.700 |
0.067 |
1.176 |
0.038 |
0.000 |
1.266 |
0.095 |
0.001 |
| (CD3+), % |
68-82 |
59.4 |
1.1 |
68.9 |
2.8 |
0.016 |
71.3 |
3.5 |
0.013 |
| T-helpers, (CD4+) 109/l |
0.357-1.254 |
0.419 |
0.035 |
0.669 |
0.034 |
0.001 |
0.724 |
0.041 |
0.001 |
| (CD3+), % |
29-55 |
36.2 |
3.3 |
39.1 |
2.1 |
0.497 |
40.9 |
1.2 |
0.228 |
| T-suppressors, (CD8+) 109/l |
0.146-0.81 |
0.304 |
0.047 |
0.520 |
0.039 |
0.008 |
0.537 |
0.008 |
0.048 |
| (CD8+), % |
20-36 |
25.3 |
2.3 |
30.4 |
2.2 |
0.162 |
29.4 |
2.8 |
0.304 |
| T-helpers/T-suppressors, (CD4+/CD8+) |
1.1-2.2 |
1.46 |
0.15 |
1.30 |
0.10 |
0.42 |
1.46 |
0.15 |
1.00 |
| B-lymphocytes, (CD19+), 109/l |
0.022-0.53 |
0.138 |
0.019 |
0.112 |
0.023 |
0.435 |
0.094 |
0.016 |
0.119 |
| (CD19+), % |
5-15 |
11.5 |
0.8 |
6.4 |
1.3 |
0.013 |
5.3 |
0.7 |
0.001 |
| IgA, g/l |
m 1.03-4.04 |
3.51 |
0.54 |
3.11 |
0.34 |
0.551 |
3.16 |
0.44 |
0.633 |
| IgG, g/l |
m 6.64-14 |
12.72 |
0.69 |
11.63 |
0.83 |
0.349 |
10.41 |
0.80 |
0.062 |
| IgM, g/l |
m 0.55-1.41 |
1.87 |
0.23 |
1.81 |
0.23 |
0.868 |
1.60 |
0.09 |
0.339 |
Erythrocytes count in patients with diabetic glomerulosclerosis and chronic renal failure grade 1 after Cell Therapy
Hemoglobin count in patients with diabetic glomerulosclerosis and chronic renal failure grade 1 after Cell Therapy
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