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June 21, 1999
We had honor to accept at our Cell Therapy Clinic of National Medical University and Embryonic Tissues Center "EmCell" Mr. R. (DOB - March 19, 1991, attended by his parents Mrs. Sh. (DOB - January 28, 1972) and Mr. A. (DOB - March 29,1961). Period of treatment - June 15 - 21, 1999.
Medical description, including a report by Dr. Judith F. Topilow Pediatrician-Muscular Dystrophy Clinic from May 26, 1998, have been considered.
Diagnosis: Muscular dystrophy.
The patient complains of the disorders of gait, weakness, inability to walk up and down stairs, falling down the floor, difficulty to get up from the floor (gets up with the help of arms). As the patient reported, the disease manifested about 2-3 years ago. Diagnosis was established a year ago.
Anamnesis vitae is narrated in details in the description from May 26, 1998. Last year the progress of the disease was more rapid then before.
No drug allergy and children infections reported.
Present condition
General condition is satisfactory. Mental and physical development - according to the age.
Hyperlordosis, walking is not firm with tiptoes going down. Skin is of a normal color. Lymphatic nodes are not enlarged - by palpation examination. Heart rate is regular, 86 bpm. Tones of the heart are regular, melody is normal, no noise at the auscultation. At percussion lung fields are clear - ordinary sound in all lines. At palpation abdomen is soft, painless. Liver is at the edge of costal arch, with no peculiarity, spleen is out of palpation reach. According to the patient, stools and urination are regular and normal.
15.06.99. Examination by Neurologist, Dr. Natalia Sedeleva, MD, Ph.D.
Anamnesis is presented in the description from May 26, 1998.
At the examination the boy is cooperative, acts according to instructions, is concentrated and serious. Visible hyperlordosis at walking. Walks with difficulty, awkwardly, due to the weakness in legs. He cannot squat and gets up with the help of his arms. Muscle strength is substantially reduced in arms and legs, more in right extremities. Hypertrophy of arm and leg muscles. Pseudohypertrophy (?) of calves. Reflexes are weak. In arms S=D. Knee reflexes are D<S. No heel tendon reflex in the right side. Positive Babinsky sign on both sides, S>D. All flexor symptoms (Behterev, Rossolimo, Zhukivsky) are present. Sensitivity is intact. Coordination test – finger-to-nose - is performed satisfactory. Face expression is quite vivid. Eye slots are symmetric, pupils D=S. The movements of eye apples to the full range, but the sight was floating, not fixed in the side positions. Convergence is not sufficient on both sides.
Diagnosis: Muscular dystrophy.
Embryonic Stem Cell Therapy is recommended.
Lab tests (blood count,chemistry,routine urine test, ECG) were normal.
21.06.99. Second Examination by Neurologist, Dr. Natalia Sedeleva, MD, Ph.D.
Patient's condition has substantially ameliorated - emotional background is more favorable, he is in good mood, more active, moves more, does not fall. The gait has improved, lordosis has diminished, he puts feet straighter, on the full foot (have performed a test of walking on tiptoes and on the heels). Instructions to squat and stand up performs as before. Muscle tone at palpation has improved in forearms and especially in the legs. Tone of both arms did not changed. Reflexes are as before except for the right heel tendon, which is now present. The pathological feet reflexes are less expressed, no Babinsky in the right side. Face expression is more vivid. Eye slots are symmetric, pupils D=S. The movements of eye apples are to the full range, the movements of both eyes are more coordinated and more fixed.
Recommendations: Repeated course of Embryonic Stem Cell Therapy in 3-4 months.
R. received a course of Embryonic Stem Cell Therapy:
06.15.99. Transplantation of sample 3038U185 i.v. dropwise, of 2 ml. Implantation of sample 3038UE185 s/c in buttocks, in three depots 0,6 ml each.
06.16.99. Implantation of sample 3038UE185 s/c in buttocks, in two depots 0,9 ml each.
06.18.99. Transplantation of sample 3038P6 i.v. dropwise, 1.5 ml. Implantation of sample 3038PM6 s/c in frontal abdomen in two depots 0.8 ml each.
06.21.99. Implantation of sample 3038PE6 s/c in buttocks, in three depots, 1.1 ml each.
The Cell suspension samples 3038U185, 3038UE185, 3038P6, 3038PM6 and 3038PE6 are certified as follows:
| Bacterial sterility test |
Negative |
| Prenatal Diagnostics |
|
| Test with cardiolipid antigen |
Negative |
| Ami - HIV1/HIV2 |
Negative |
| HBsAg |
Negative |
| Embryonic Diagnostics |
|
| Enzygnost Ami - HIV1/HIV2 |
Negative |
| HBsAg monoclonal |
Negative |
| Anti - HBc monoclonal |
Negative |
| Anti - CMV/IgG+IgM |
Negative |
| Anti - Rubella Virus/IgG |
Negative |
| Varicella/Zoster |
Negative |
| Toxoplasmosis/IgG |
Negative |
Results of the Treatment
Emotional condition has improved, the boy became more active and lively. Gait is more confident, better coordinated, increased strength in forearms and legs. If before the treatment he fell down 3-4 times per day, after the treatment, according to his parents, he did not fall down for the past 3 days. Drags tiptoe less at walking, puts feet more firmly and confidently, lordosis is less expressed. He can walk for long distances with less effort. Corresponding changes in neurological symptoms are described by Dr. N. Sedeleva.
Mr. R. is recommended:
1. Follow up by the neurologist in the USA.
2. Diet rich with proteins (veal, fish, mushrooms, etc.).
3. Regular training including movement activities involving legs and arms.
4. Avoid infections.
5. Report (subjective by parents and professional (objective) by neurologist) once a month.
6. Repeated course of cell therapy in September-October of 1999. The exact timing of the visit is to be arranged in accordance with the dynamics of the patient's condition.
Head of the Cell Therapy Clinic of National Medical University and Embryonic Tissues Center "EmCell" Professor Alexander Smikodub
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