Clinical Outcomes of Transplanted Modified Bone Marrow–Derived Mesenchymal Stem Cells in Stroke A Phase 1/2a Study

Was this good enough results to create a protocol on this and if so, what hospitals are using it? It is only 4.5 years old. Good that this was testing in chronic.

Another article on this in New Scientist mentions the participants received 2.5, 5, or 10 million cells which seems miniscule compared to the billions we have lost. Run by SanBio of Mountain View, CA.

Clinical Outcomes of Transplanted Modified Bone Marrow–Derived Mesenchymal Stem Cells in Stroke; A Phase 1/2a Study

Gary K. Steinberg

,

Douglas Kondziolka

,

Lawrence R. Wechsler

,

L. Dade Lunsford

,

Maria L. Coburn

,

Julia B. Billigen

,

Anthony S. Kim

,

Jeremiah N. Johnson

,

Damien Bates

,

Bill King

, … See all authors

Originally published2 Jun 2016https://doi.org/10.1161/STROKEAHA.116.012995Stroke. 2016;47:1817–1824

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Abstract

Background and Purpose—

Preclinical data suggest that cell-based therapies have the potential to improve stroke outcomes.

Methods—

Eighteen patients with stable, chronic stroke were enrolled in a 2-year, open-label, single-arm study to evaluate the safety and clinical outcomes of surgical transplantation of modified bone marrow–derived mesenchymal stem cells (SB623).

Results—

All patients in the safety population (N=18) experienced at least 1 treatment-emergent adverse event. Six patients experienced 6 serious treatment-emergent adverse events; 2 were probably or definitely related to surgical procedure; none were related to cell treatment. All serious treatment-emergent adverse events resolved without sequelae. There were no dose-limiting toxicities or deaths. Sixteen patients completed 12 months of follow-up at the time of this analysis. Significant improvement from baseline (mean) was reported for: (1) European Stroke Scale: mean increase 6.88 (95% confidence interval, 3.5–10.3; P<0.001), (2) National Institutes of Health Stroke Scale: mean decrease 2.00 (95% confidence interval, −2.7 to −1.3; P<0.001), (3) Fugl-Meyer total score: mean increase 19.20 (95% confidence interval, 11.4–27.0; P<0.001), and (4) Fugl-Meyer motor function total score: mean increase 11.40 (95% confidence interval, 4.6–18.2; P<0.001). No changes were observed in modified Rankin Scale. The area of magnetic resonance T2 fluid-attenuated inversion recovery signal change in the ipsilateral cortex 1 week after implantation significantly correlated with clinical improvement at 12 months (P<0.001 for European Stroke Scale).

Conclusions—

In this interim report, SB623 cells were safe and associated with improvement in clinical outcome end points at 12 months.

Clinical Trial Registration—

URL: https://www.clinicaltrials.gov. Unique identifier: NCT01287936.