Autologous Stem Cell Transplantation

in Patients with chronic Spinal Cord Injury
(n=85)

Introduction
Because Autologous Stem Cells from bone marrow are easily accessible from both healthy donors and pa1 tients and can be expanded on a therapeutic scale, they have attracted attention for cell-based therapy . Although the mechanisms are not yet completely understood, some small clinical trials with Spinal Cord Injury patients have demonstrated a positive effect on their use and proved that the use of Autologous Stem 2-4 Cells is safe .

Methods
On a larger scale XCell-Center treated chronic Spinal Cord Injury Patients with Autologous Stem Cells using the Lumbar Puncture procedure 200 ml of Bone Marrow was extracted out of the Iliaca crest and was concentrated for transplantation using gradient centrifugation (mean number of given cells was 6.000.000). After treatment the patients were evaluated using a Post Treatment Survey. The results of surveys of 85 patients treated with autologous stem cell transplantation were evaluated and are presented in this poster.

Results
The picture on the right shows the distribution of the patients by severity of the Spinal Cord Injury lesions of the treated patients. The side effects reported by the patients were caused by the Lumbar Puncture treatment and not by the stem cells. The most common side effect was a short period of mild headache (15% of the patients). Nearly 60% of the treated patients experienced improvements. There was nearly no difference between patients classified as an ASIA A (complete Spinal Cord Injury) and patients classified with an ASIA B or C (incomplete Spinal Cord Lesion). The figure below illustrates the kind of improvements. Getting back sensation (feeling warm or cold sensations/ touch) was reported in 40% of all patients. Less weakness and a longer time of muscle activity was reported in more than a quarter of the treated patients. Better control of Bladder and Bowel and even getting back erections was also reported by more than 10% of the patients. The results show no apparent correlation between the outcome and the used number of transplanted stem cells.

SCI - Class of Spinal Cord Injury
1. Severity of the Spinal Cord Injury Complete SCI lesion Incomplete SCI lesion
50% 100%

Overview type of Spinal Cord Injuries (N=85)

31 54

Para Plegic

42

2. Level of Spinal Cord Injury lesion High cervical lesions (c1-c4) Low cervical lesion (c5-c7) Others
0%

Quadra Plegic

36

20 29

43

3. Functional Impairment

Complete and incomplete spinal cord lesions (85)
100%

SCI - Class of Spinal Cord Injury

51

50%

32

+

Deterioration

2

No Change

Improvement

0%

Spinal Cord Injuries

Efficacy by Complete or Incomplete Spinal Cord Injury (N=85)

SCI – Results of Stem Cell Treatment

Table: Improvements type of Spinal Cord Injury
(complete or incomplete lesion / N=85)
Improvements Counts (%) No improvements Counts (%) Total SCI patients Counts (%)

Complete SCI Injury Incomplete SCI Injury Total SCI patients

21 30 51

(67,7%) (55,6%) (60,0%)

10 24 34

(32,3%) (44,4%) (40,0%)

31 54 85

(100%) (100%) (100%)

Conclusions
In summary, Autologous Stem Cells injected in the spinal cavity has proven to have a positive effect on the Spinal Cord Injury by nearly 60% of the treated patients.

Complete Spinal Cord Injuries (n=21/N=31)
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%

Type of improvements SCI

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References

1. Dezawa M. Systematic neuronal and muscle induction systems in bone marrow stromal cells: the potential for tissue reconstruction in neurodegenerative and muscle degenerative diseases. Medical molecular morphology. Mar 2008;41(1):14-19. 2. Deda H, Inci MC, Kurekci AE, Kayihan K, Ozgun E, Ustunsoy GE, Kocabay S. Treatment of chronic spinal cord injured patients with autologous bone marrow-derived hematopoietic stem cell transplantation: 1-year follow-up. Cytotherapy. 2008;10(6):565-574. 3. Bakshi A, Barshinger AL, Swanger SA, Madhavani V, Shumsky JS, Neuhuber B, Fischer I. Lumbar puncture delivery of bone marrow stromal cells in spinal cord contusion: a novel method for minimally invasive cell transplantation. Journal of neurotrauma. Jan 2006;23(1):55-65. 4. Mackay-Sim A, Feron F, Cochrane J, Bassingthwaighte L, Bayliss C, Davies W, Fronek P, Gray C, Kerr G, Licina P, Nowitzke A, Perry C, Silburn PA, Urquhart S, Geraghty T. Autologous olfactory ensheathing cell transplantation in human paraplegia: a 3-year clinical trial. Brain. Sep 2008;131(Pt 9):2376-2386. 5. Frank RL. Lumbar puncture and post-dural puncture headaches: implications for the emergency physician. The Journal of emergency medicine. Aug 2008;35(2):149-157.

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The used procedure is safe and the most reported complaint by the patients was a short period of mild Headache. Comparing the results of the side effects survey of XCell-Center (this survey consists of 350 patients) with international literature, XCell-Center showed one of the lowest incidence of Post Dural Puncture Headache 5 (3,7%) .

No Yes
28,6% 9,5% 28,6% 38,1% 28,6 % 52,4% 33,3% 23,8% 4,8%

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