BM-MCS Accelerates Acute Stroke Recovery In A Randomized Placebo-controlled Clinical Phase Ii/iii Study

  • Journal: Cytotherapy 2016; 18 (6S):S8
  • Authors: N. Mohamed Ibrahim¹ , H. Tan¹ , S. Chin² ∙ Z. Law¹ ∙ N. Ismail³ ∙ N. Amran@Azman² ∙ S. Cheong²,⁴ ∙ S.S. Abdul Wahid¹,³

Background

We previously demonstrated that mesenchymal stromal cell (MSC) may be transdifferentiated into neuron-like cells. MSC may also help attenuate cerebral oedema and hasten recovery following acute stroke. Furthermore, the blood-brain barrier is semipermeable in the acute stroke period which allows MSC to be administered intravenously.

Methods

Seventeen patients with acute middle cerebral artery stroke were recruited and randomized to receive best medical care plus autologous bone marrow-derived MSC (Group A-MSC; n = 9) or best medical care alone (Group B- Placebo; n = 8). There were no significant differences in age or comorbidities. Group A patients received 100–200×106 MSC intravenously at 1 month after acute stroke. The internationally-validated scales of Barthel index (BI), National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Score (mRS) were used to record the disability and functional progress at baseline (stroke onset), 6 weeks, 3 months, 6 months and 12 months follow up.

Results

All patients were severely disabled following acute stroke (Baseline [Mean ± 1SD] for mRS [4 ± 1]; BI [14 ± 17] and NIHSS [17 ± 6], no difference between both arms. One patient died in each group due to sudden death (Group A) and septicaemia secondary to pressure sores (Group B). Both groups showed improvement in NIHSS, BI and mRS over time but the improvement was only significant in Group A. Intergroup comparison revealed that mean BI was higher for Group A at 6-weeks follow-up when compared to Group B (70 ± 31 vs 26 ± 38, P = 0.041). There were continuing improvement in BI in Group A at 6 and 12 months compared with Group B but not significant [6 months (85 ± 11 vs. 55 ± 46, P = NS) and 12 months (91 ± 8 vs. 67 ± 58, P = NS)].  

Conclusion

MSC administered intravenously in the sub-acute period following severe stroke is safe and efficacious, and results in accelerated recovery in the initial period. More studies are warranted.

Affiliations

  1. Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia
  2. Cytopeutics, Selangor, Malaysia
  3. Cell Therapy Centre, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia
  4. Tunku Abdul Rahman University, Selangor, Malaysia
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