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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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News about cell transplantation

EmCell delegates participated in the III International Symposium
2005-04-12

EmCell delegates participated in the III International Symposium on the Clinical Use of Cellular Products held in Regensburg, Germany, on March 17-18, 2005.

Presented were the following abstracts

Embryonic Stem Cells in Rheumatoid Arthritis 

Smikodub O.I., Demchuk M.P.

Cell Therapy Clinic of National Medical University and Embryonic Tissues Center EmCell

Over a period of 9 years, monitored was a group of patients with 1,5 –20-year history of confirmed rheumatoid arthritis (RA) in whom observed were drug intolerance or inefficiency of routine methods, and marked limitation of functional capacity.  For treatment, used were cryopreserved embryonic stem cell (ESC) suspensions containing hematopoietic and non-hematopoietic mesenchymal stem cells.  ESC suspensions were prepared from organs of 4-8 weeks old embryonic cadavers obtained from legal abortions.  Total nucleated cell count – 10-400x106/ml, mononuclear cell count – 10-100x104/ml.  Upon ESC administration, all patients reported the Syndrome of Early Post-Transplant Improvements manifested by decreased general weakness, subsidence of pain, improved and more optimistic mood, improved appetite and normalized sleep formula.  This method of treatment allowed for the decrease of the degree of the inflammatory activity, from high (14 points) to minimal (3 points), and achievement of clinical remission in 85% of cases. 
 
Over a period of one year, patients under observation reported decrease of pain, articular, and inflammatory indices - main clinical criteria of RA manifestations, functional capacity increase manifested by the ability of performing everyday activities patients were unable to perform prior to this treatment, improved gait, ability to use public transport and continue full-time work.  Subsequent transplantations were performed in 62% of cases: 80% of them were aimed at functional capacity and life quality improvement, and only 20% were performed for the decrease of the disease activity. 
 
Immunocorrecting effect of ESC was observed in all the patients.  Reported was increase of T-suppressor count (CD8+); helper/suppressor ratio CD4+/CD8+ decreases over a period of 360 days.  Prior to the treatment, rheumatoid factor titer amounted to 3.2 U, and within 360 days, it decreased to 1,02 U. 
 
Bioethical principles on application of embryonic cell suspensions were strictly adhered to at all the stages of the research. 



Embryonic Stem Cells in Non-Specific Ulcerative Colitis and Crohn’s Disease

Smikodub O.I., Bushneva V.O.

Cell Therapy Clinic of National Medical University and Embryonic Tissues Center EmCell

Cryopreserved hematopoietic and non-hematopoietic mesenchymal embryonic stem cells (ESC) were used in complex treatment of 25 patients with non-specific ulcerative colitis (UC) and 15 patients with Crohn’s disease (CD).  ESC suspensions were prepared from 4-8 weeks old human embryonic cadavers obtained from legal abortions.  Total nucleated cell count – 10-400x106/ml, mononuclear cell count – 10-100x104/ml. 

Indications for ESC application: exacerbation of the disease resistant to routine treatment, extraintestinal complications, cachexia, impossibility of surgical treatment due to contraindications, difficulties in finding the matched blood type for transfusion or donor-recipient incompatibility revealed by compatibility tests, growth and developmental delay in children.

Observed was dynamics of clinical symptoms, hematological and immunological parameters.  One month after transplantation, stool frequency decreased 6-8-fold, stool became formed or semi-formed in 96% of cases; blood disappeared in 63% of cases, mucus – in 54%, pus – in 100%.  Tenesmus was reported in 1% of patients, abdominal pain – in 7%, fevers – in 5%.  After 12-36 months, colonoscopy revealed decrease of left-side lesion to proctitis or proctosigmoiditis in 10% of UC patients.

In the main group of UC patients, remission was achieved in 35% more cases, than in the reference group, and its duration was by 51% higher.  In the main group of CD patients, remission was 2,2 times longer.

Improved were also hematological findings: erythrocyte count increased 30-59 days after transplantation, and hemoglobin level – in 60-89 days.  Two types of immune response were distinguished in post-transplant period: 1 (43%) – due to systemic apoptosis of lymphocytes – sharp decrease of absolute counts of all lymphocyte subpopulations in peripheral blood observed 1-2 weeks after transplantation in patients with highly active inflammatory process and aggravated disease was followed by decreased disease activity and improvement of clinical and rectoscopic findings.  3 months after transplantation, reported was reliable increase of immunological findings.  Type 2 immune response was characterized by the increase of the absolute counts of lymphocyte subpopulations 2-4 weeks after transplantation and was observed in 57% of cases, mostly in chronic and recurring forms of the moderately severe disease.

Application of this method allowed for decreased activity of the inflammatory process and achievement of the remission in cases where routine therapy with aminosalycylates and glucocorticoids proved ineffective.  ESC transplantation allowed for discontinuation of hormone-dependency in 5% of patients and avoidance of surgical intervention at given stage of the treatment in 15% of patients. 



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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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