The surgery is performed for the purpose of disrupting an intramedullary cyst and infilling the spinal cord defect with the fibrin gel containing immature (stem) cells. Following the surgery, a patient is grafted subarachnoidally with the cells one or more times. The treatment is conducted in the neurosurgical department.
Effect
The grafted cells release a variety of axonal growth-stimulating, neurotrophic factors, but also participate immediately in restoring affected nervous communications.
Infectious safety
The donor material is subjected to 3-level testing for infection (2 immunoenzyme analyses and 1 PCR examination).
Side effects
Typical surgical complications cannot be entirely excluded. No long-term complications are registered.
Stem cell transplantation for spinal cord injury (sci)
The original cell transplantation technology has been developed in the Centre for treating SCI patients. After surgically disrupting an intramedullary cyst (see Figure 1), the spinal cord defect is entirely filled up with the special gel containing fetal-derived, immature (stem) cells (see Figure 2). Moreover, during several months after the surgery each patient is subarachnoidally grafted with fetal-derived cells one or more times. The donor cell combination that is highly effective in generating regenerative processes in an adult nervous tissue has been previously determined by special experimental studies.
Figure 1 : Dissection of the connective tissue cyst and opening access to the cord defect
Figure 2 : Infill of the spinal cord defect with the cell- containing gel implant
By present a total of 122 SCI patients have been subjected to the cell transplantation treatment . In nearly 60 % patients the severity of SCI was initially characterized by complete motor/sensory function disorder lower an injured level (A grade of SCI).
The posttraumatic time was from several months to 5 years. The outcomes of treating the patients with the follow-up times of 2 years or longer are shown in Table 1.
Neurological status in terms of ASIA definition before CT treatment
Neurological status after CT treatment (% patients)
A
B
C
D
A (73 patients -100%)
31%
48%
18%
3%
B (49 patients-100%)
-
78%
22%
-
[ Table 1. The outcomes of treatment of SCI patients ]
A, complete motor and sensory function disorder;
B, motor complete, sensory incomplete function disorder;
C, motor and sensory incomplete function disorder;
D, useful motor function with or without auxiliary means (a strength in most muscles is of 3 points or more)
As can be seen, the various clinical improvements were noted in more than the half of cell-transplantation -treated patients. It should be noted that neurological changes in the cell-grafted patients are being developed gradually for a long time (3 years and longer) and, therefore, the presented data are not final and may be changed in the course of time. The cell transplantation treatment is safe and well tolerated; no serious complications related to grafted cells were noted. Thus, the stem cell-based technology opens new feasible opportunities for effective treatment of SCI patients.
The examples of applying the cell transplantation treatment are described in detail below.
A 31 year-old male patient A has been affected between T12 and L1 spinal level as a consequence of a parachute jump. The time period between receiving SCI and starting the cell transplantation treatment was 1.5 years. Before CT treatment his neurological status had the following characteristics: inferior flaccid paraplegia (strength was less than 2 points); profound conductive disorders of all kinds of sensitivity lower an inguinal fold level; disfunctions of pelvis organs.
The patient was subjected to the surgery ( destruction of an intramedullary cyst and implantation of donor cells into the made cavity) plus 1 subarachnoidal cell transplantation.
At 6 months after CT treatment the patient exhibited complete restoration of all kinds of sensitivity and effective control over functions of pelvis organs. The patient became able to exert flexions in hip and knee joints of both legs without any assistance and to retain legs in a bended position (see Figure 3).
Figure 3 : Patient a bends his legs without any assistance and retains them in a bended position
A neuromyographic examination revealed the appearance of a clear conductivity of biopotentials in lower extremities (see Figure 4).
Figure 4 : The conductivity of biopotentials in the lower extremities of patient A
A 24 year-old male patient Z has been affected at ?7 level in consequence of a road traffic accident. The posttraumatic time was 2 months. Before the cell transplantation treatment his neurological status had the following characteristics: superior paraparesis; inferior flaccid paraplegia; profound conductive disorders of all kinds of sensitivity lower Th1 level; disfunctions of pelvis organs. MRI examination revealed deformation and size diminution of C6-?7 vertebral bodies. At C6-?7 level Ti-Ni implant was visualized. The spinal cord was thin at the injured level, but its continuity was not broken. The intramedullary cyst of 1.01 ? 0.2 cm was clearly visualized at ?7 segment (see Figure 5 A). At Th1-3 level the spinal cord heterogeneity with the hyperintensive areas of up to 0.12 cm were detected in T2 regime.
The patient was subjected to the surgery (a partial destruction of an intramedullary cyst and implantation of donor cells into the made cavity) plus 3 subarachnoidal cell transplantations at 14 day intervals. At 120 day after the cell transplantation treatment, on MRI scan the areas of various densities with indistinct contours were seen in the field of the former cyst ( see Figure 5 B). Those areas might be visible manifestation of regenerative activity of the grafted cells.
Figure 5 (A, B, C). MRI scan of patient Z before (A), at 4 months (B), and 4 years after the cell transplantation treatment (C).
Benefits from cell transplantation t were developing gradually in the patient as long as during 4 years. The dynamics of neurological changes is presented in Table 2.
The time after CT treatment (years)
Clinical data
Strength in hands (poinst)
Range of motions in fingers
Range of motions in legs
Level of painful sensitivity
Urination
0.5
2
No
No
Th 2-Th3
Incontinence
1
2
Flexion, opening extension
Motions in the first finger of the right foot
Th 6-7
Control over 3-to-4 hours
2
3-4
Flexion, opening extension
contracting activity in some hip muscles
Complete restoration of all kinds of sensitivity
Complete restoration
4
5
Complete restoration
contracting activity in shank muscles
Complete restoration of all kinds of sensitivity
Complete restoration
[ Table 2. The dynamics of neurological changes in patient Z ]
Finally, MRI revealed no spinal cord pathology (see Figure 5 C). All kinds of sensitivity were completely recovered; functions of pelvis organs were self-controllable; the strength in arms reached for 5 points. The patient recovered his moving activity to an extent that he was able to walk with support (see Figure 6).
Figure 6. Patient Z completely recovered his motor activity in hands, and could move with support.
A 52-year-old male patient K has been affected at C3-C6 level in consequence of a road traffic accident. The time period between receiving SCI and starting the cell transplantation treatment was 4 days. Before this treatment his neurological status had the following characteristics: tetraplegia; profound disorder of all kinds of sensitivity lower Th1 level; disfunctions of pelvis organs. The palpation of ?3-to-C6 vertebras was painful. X-ray examination failed to reveal any traumatic bone changes in cervical spine. MRI showed a rounded area (0.7 x 0.5 cm) of hypointensity with clear-cut contours at C3-C4 junction and a centro-dextral spindle-shaped 5.8 x 0.3 cm area giving signal of increased intensity at T2 regime along the whole length from C2 to C5 level (see Figure 7 A).
The patient was subjected to 2 subarachnoidal cell transplantations at a 14 day interval. On 44th day after the treatment MRI scan showed an intramedullar heterogeneous formation with indistinct contours (the cyst might presumably be embedded in neural cell graft) at C7, as well as the normal thickness and structure of the spinal cord bellow the spinal cord lesion (see Figure 7 B)
Benefits from the treatment were developing gradually in the patient as long as during 4 years. Finally, MRI revealed no spinal cord pathology (see Figure 7 C). All kinds of sensitivity were completely recovered; functions of pelvis organs were self-controllable; the strength in arms reached for 5 points. The patient recovered his moving activity to an extent that he could walk with outside assistance (see Figure 8).
Figure 7 (A,B,C). MRI scan of patient ? before (A), on 44 day (B) and at 4 years after the cell transplantation treatment (C).
Figure 8. Patient K is walking with outside assistance.
A 18 year-old male patient S has been affected at C5 level in consequence of his diving . The time period between receiving SCI and starting the cell transplantation treatment was 1.5 years. Before the treatment his neurological status had the following characteristics: tetraplegia; profound disorder of all kinds of sensitivity lower Th1 level; disfunctions of pelvis organs. The intramedullary cyst overriding 2/3 spinal cord at ?5-6 level was clearly visualized on a MRI scan (see Figure 9 A).
The patient was subjected to the surgery (destruction of an intramedullary cyst and implantation of donor cells into the made cavity) plus 3 subarachnoidal cell transplantations at 30 day intervals.
At 2 years after the treatment the strength in patient's hands restored to 4 points, urination was self-dependent, recovery of both tactile sensation and musculoarticular sense was noted on the right. In addition, some contracting activity was found in femoral muscles. The patient could stand on his knees leaning against a floor by his hands. He became capable of working on a computer. Disappearance of the intramedullary cyst, as well as restoration of his spinal cord integrity was noted on MRI scan (see Figure 9 B).
Figure 9 (A,B). MRI scan of patient S before (A) and at 2 years after the cell transplantation treatment (B).
23 year-old male patient V has been affected at C5 level in consequence of a road traffic accident. The time period between receiving SCI and starting the cell transplantation treatment was 3 years. Before the treatment his neurological status had the following characteristics: superior paraparesis (the strength in arms was less than 2 points); inferior flaccid paraplegia; profound conductive disorders of all kinds of sensitivity lower the spinal lesion level; disfunctions of pelvis organs. At the injured level a cyst was clearly visualized on a MRI scan.
The patient was subjected to the surgery (destruction of an intramedullary cyst and implantation of donor cells into the made cavity) plus 2 subarachnoidal cell transplantations at a 14 day interval.
At 1.5 year after the treatment the site of a former cyst was mostly filled with a nervous tissue, as revealed by MRI (see Figure 10). The patient exhibited a recovery of both sensitivity and an effective control over bladder function. The strength in his right and left hand was of 5 and 3 points, respectively. He became capable of writing, working on a computer and driving a car (see Figure 11).
Figure 10. MRI scan of patient V at 18 months after the cell transplantation treatment.
A 18 year-old female patient ? has been affected at ?6 level in consequence of a road traffic accident. The time period between receiving SCI and initiating the cell transplantation treatment was 2 years. Before the treatment his neurological status had the following characteristics: superior paraparesis (strength in arms was less than 2 points); inferior flaccid paraplegia; profound conductive disorders of all kinds of sensitivity lower the spinal lesion level; disfunctions of pelvis organs.
The patient was subjected to the surgery ( destruction of an intramedullary cyst and implantation of donor cells into the made cavity) plus 2 subarachnoidal cell transplantations at a 14 day interval.
At 12 months after the treatment the patient exhibited complete restoration of all kinds of sensitivity and effective control over functions of pelvis organs. She could write, embroider, stand with support and walk with orthosis
A 25-year-old male patient T has been affected at Th6 level in consequence of a road traffic accident. The time period between receiving a trauma and starting the cell transplantation treatment was 4 months. Before the treatment his neurological status had the following characteristics: inferior flaccid paraplegia; profound conductive disorders of all kinds of sensitivity lower Th5 level; disfunctions of pelvis organs. MRI scan showed deformation and size diminution of Th6 vertebral body. The spinal cord was thin at the injured level, but its continuity was not broken. At Th6, a 3.0 ? 0.5 cm intramedullary cyst was clearly seen. The spinal cord heterogeneity with the hyperintensive areas of up to 0.7 cm at was also visualized in T2 regime.
The patient was subjected to the surgery ( destruction of an intramedullary cyst and implantation of donor cells into the made cavity) plus 3 subarachnoidal cell transplantations at 30 day intervals. At 12 months after the treatment the patient exhibited complete restoration of all kinds of sensitivity, effective control over functions of pelvis organs, and evident improvements in motor sphere: he could walk sufficiently without any help.
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