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November 20, 2000
We had honor to accept at our Cell Therapy Clinic of National Medical University and Embryonic Tissues Center "EmCell" Mr. R. (DOB - March 19 attended by his parents Mrs. Sh. (DOB - January 28, 1972) and Mr. A. (DOB - March 29,1961). This is his fourth visit to our Clinic. Period of treatment - November 13- 20, 2000.
Diagnosis: Duchenne Muscular Dystrophy.
11.13.00 Examination by the Head of Cell Therapy Clinic, Professor Alexander Ivanovich Smikodub.
R. is a 9-year-old boy. This is his fourth visit to Cell Therapy Clinic in Kiev. We think that his disease – Duchenne Muscular Dystrophy – hasn’t worsened and we can trace definite positive changes. The boy has grown by 4 cm, his height is now 140 cm (4 feet 8 inches). His weight has increased by 2 kg, at present he weights 40 kg (88 pounds). The child walks actively, his improved gait has been preserved, leans on his heel. Lordosis has reduced. Muscle tone of the extremities is normal. Shoulder muscles are being restored. Hypotrophy of the back muscles is still observed. According to his parents, the child falls only because of his foot problem (hovering), especially when he raises his leg to get over a small height (e.g. threshold, stairs). Regular falls – without reason - are not observed. The child cannot squat, and cannot get up from the floor. He can raise his arms well.
Skin coats are clean, fat deposits in the abdominal area.
Tones of the heart are loud, rhythmical. Lung fields are clear. At palpation his abdomen is soft and painless. Urination and defecation are regular.
As boy reported, he feels better from the time of his previous visit to the Clinic, his physical ability has improved.
11.13.00. Examination by Neurologist, Dr. Natalia Sedeleva, MD, Ph.D.
The child has come for the next course of cell therapy (4thcourse). The first course was carried out in June 1999, the last – in May 2000.
During the last 6 months the child has grown up and gained weight.
His attitude to the forthcoming examination is positive – he is friendly, notes the improvements of his condition. According to his parents, his mood is stable, he is optimistic, studies well, does a lot of movement activity, swims in the pool. He doesn’t fall when he walks; at walking his legs are extended, steps on the full foot. Cannot squat.
In neurological status: lid slits and eye pupils s=d, the movement of eye balls to the full capacity, convergence is good on both sides. Swallowing without problems. Muscle tone in the left hand and leg is close to normal, in the right extremities it is reduced, strength in arms and legs is weakened, d=s, but he can raise his hands and bend his legs. Hand reflexes – s=d, of medium strength, knee reflexes are weak, without side difference, heel reflexes are strong, d < s; foot reflexes on both sides, weaker on the left. Coordination tests are performed well. Sensibility is preserved.
Marked positive influence of the therapy is reflected in inhibition of the manifestations of the disease, gain of muscle volume and growth of the body.
Diagnosis: Myodistrophy.
Lab tests (blood count, chemistry, routine urine test) were normal.
Recommendations: continue cell therapy.
R. received a course of Cell Therapy:
11.13.00. Transplantation of sample 3038A892 (human embryonic cell suspension) intravenously dropwise, 1.2 ml. Implantation of sample 3038??892, s/c in frontal abdomen, in two depots, 0.9 and 0.2 ml.
11.14.00. Transplantation of sample 3038A892 (human embryonic cell suspension) intravenously dropwise, 1.2 ml. Implantation of sample 3038AM892, s/c in buttocks, in two depots, 0.6 ml each.
11.15.00. Implantation of sample 3038AM892, s/c in buttocks, in three depots, 1.0 ml each.
11.17.00. Transplantation of sample 3038H615 (human embryonic cell suspension) intravenously dropwise, 1.6 ml. Implantation of sample 3038HM615, s/c in frontal abdomen, in two depots, 0.6 ml each; in buttocks, in two depots, 0.7 ml each; 3038HM615 i.m.
11.20.00. Implantation of sample 3038HM615, s/c in buttocks, in one depot, 1.0 ml; 3038HM615 i.m. 0.3 ml in buttocks.
General conclusion: administration of embryonic cell suspensions was well tolerated; reactions to the material (reddening of the skin, edema of the hypodermic adipose cellular tissue) were noted only at the first implantation. The boy felt himself stronger, the endurable physical load has increased, the gait has somewhat improved. According to his mother, he began to get off the bed better, the abduction of his legs during exercises has improved, can bend his knees better at the attempt to squat.
The Cell suspension samples 3038A892, 3038AM892, 3038H615, and 3038HM615 are certified as follows:
| Bacterial sterility test |
Negative |
| Prenatal Diagnostics |
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| Test with cardiolipid antigen |
Negative |
| Ami - HIV1/HIV2 |
Negative |
| HBsAg |
Negative |
| Embryonic Diagnostics |
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| 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 |
R. is recommended:
1. Monthly neurological examination.
2. Diet rich in proteins.
3. Physical load regime. Monthly measurements of height and weight.
4. Avoid infections.
5. Repeated course of therapy at the Cell Therapy Clinic in May 2001.
Head of the Cell Therapy Clinic of National Medical University and Embryonic Tissues Center "EmCell"
Professor Alexander Smikodub
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