OWN UMBILICAL CORD BLOOD STEM CELLS TRANSPLANTATION

At the Mardaleishvili Medical Center an own umbilical cord blood stem cells transplantation to patients with autism clinical study is conducted. Patients with childhood autism and autistic spectrum disorders can participate in the treatment. The treatment by nature is injection of patient’s own umbilical cord blood stem cells into the spinal cord area (intrathecally) and intravenously.

Procedure

Patient is admitted to our clinic in the morning. On the empty stomach the patient has pre-surgery examinations done (complete blood count, coagulogram, immune phenotyping of lymphocytosis (CD3, CD4, CD8, CD19, CD25, CD56), determination of blood group and rhesus, serum screening for viruses (HIV, HCV, HBV), liver and kidney function (ALT, AST, total bilirubin, creatinine, blood urea, blood glucose), leukocytolysis – allergy tests to the products to be used for anesthesia of the patient, ECG, spinal X-ray, if necessary). If patient doesn’t have the results of any tests, which they had to admit before arriving to clinic (e.g. genetical test, or something else) these tests can be held here.

Next day, starting from morning on the empty stomach (minimum 5 hours before procedure the patient must not take food or drink) will be held the procedure of transplantation.

Defrosting of frozen (cryopreserved) umbilical cord blood cells and their preparation for transplantation

A tube or cryobag with patient’s frozen umbilical cord blood is placed into a water bath with the temperature of 37 C. After 5 minutes the suspension will melt dawn and washing of cells with a buffer solution (DPBS) will be conducted, added substances will be completely removed from the suspension. The process is conducted at the laboratory and takes 30-40 minutes. Suspend the washed cells in 1 ml of physiological solution and send to the surgery. As soon as the cell suspension gets into the surgery unit, preparation of patient for lumbar puncture is done straight away (i.e. for the injection of stem cells into the spinal canal). General anesthesia is conducted after intravenous injection of Dormicum or Diazepam antianxiety drug to the patient. A specialist injects the prepared part of suspension into the spinal canal and another part is injected intravenously.

Spinal canal puncture or lumbar puncture

The puncture is done between the third-fourth lumbar vertebra. After treatment of the wound with alcohol iodine solution is applied in the area of lumbus, which subsequently is removed with alcohol. The patient is asked to lower the head and lower limbs down at maximum. Use a needle with mandrin, 5-10 cm length, 2-3 mm diameter. The puncture is done lower than the third lumbar vertebra, the needle gets into the subarachnoid cavity in the area of cauda equina. In this area there is already no spinal marrow, it ends at the level of the first vertebra and that is why its damage during puncture is excluded. After the puncture with a needle, a syringe with therapeutic cells (the volume is 1 ml) is attached to it, and cerebrospinal fluid is injected. Then the needle is removed, the puncture site is treated with iodine solution and a plaster is applicated. After the puncture the patient lies on the back, with no pillow for 2-3 hours. During the same period the patient is monitored in the intensive and post-surgery care unit. After awakening of the patient the monitoring continues in the post-surgery unit, and after 2-3 hours he (she) is transferred to a private ward, he (she) continues to be monitored for the detection of possible complications. In case of absence of complaints in the morning of day 2 the patient is discharged from the hospital.

Intravenous transfusion

The procedure is done in the surgery unit directly after the lumbar puncture. Stem cells suspension is diluted in a 50 ml syringe infusion pump, diluted in 50 ml of physiological solution, and the transfusion goes on using the infusion pump for 10 minutes.

Monitoring of patient is conducted in the intensive care unit and in the post-surgery department. After awakening of the patient the monitoring continues in the post-surgery unit, and after 2-3 hours he (she) is transferred to a private ward, he (she) continues to be monitored for the detection of possible complications. In case of absence of complaints in the morning of day 2 the patient is discharged from the hospital.

About possible complications of using own umbilical cord blood stem cells

In case of use of own (autogenic) not multiplied umbilical cord blood stem cells, no hazard for the immune compatibility or any even insignificant theoretical genetic variation. According to the up to date experience no any serious complications, including the risk of tumor development, have been reported in the use of many thousands of stem cells. In the complications include side effects, developed during the first days after the procedure. They are reported quite rarely and may be both side effects related to the injection of cells, and related to the anesthesia and lumbar puncture.

Contraindications for lumbar puncture

Epidural infection, skin infection at the site of puncture, coagulopathy (blood-clotting disorder), low platelet count ((<50 х 10⁹/l), acute infection, aggravation of any chronic disease, temperature (>37,5), anticoagulants (for example, warfarin, heparin, low molecular weight heparins), antiaggregants (for example, aspirin, clopidogrel), non-steroidal anti-inflammatory agents (for example, indomethacin, diclofenac, ibuprofen). In this case it is necessary to discontinue administration of these products in advance:

• in case of heparin and low molecular weight heparins – 12-24 hours before.
• in case of warfarin – 5 days before;
• in case of aspirin and other non-steroid anti inflammatory agent – 3 days before;
• in case of clopidogrel – 9 days before.

Early complications directly related to the administration of the cell suspension include:

• In rare cases mild hypersensitivity reactions may develop, for example, non-intensive allergic cough and erythema – hyperemia. Acute anaphylaxis is not described, theoretically it can’t be excluded, though the method used in preparation of stem cells almost completely excludes the injection of foreign allergens. As nerves system disorders patients may have mild excitability, which spontaneously resolves 1-2 days after the transplantation.
• The development of a severe hypersensitivity reaction may be expected only within the first hour after the transplantation. During this period the patient is monitored in the surgery unit.

For more detailed information, please contact to the International Department of clinic!