title: Stem cell therapy: a clinical trial of stroke.
abstract: BACKGROUND
  The alarming disability burden and a high prevalence rate of stroke in India has encouraged the researchers to develop regenerative therapies to reduce clinical deficits. This study evaluates safety, feasibility and efficacy of autologous mononuclear and mesenchymal cell transplantation in stroke patients evaluated on clinical scores and functional imaging (fMRI and DTI).
  
  
  METHODS
  Forty (n=40) stroke patients were recruited with the inclusion criteria as: 3 months to 2 years of index event, power of hand muscles of at least 2; Brunnstrom stage: 2-5; conscious and comprehendible. Fugl Meyer (FM), modified Barthel Index (mBI), Medical Research Council (MRC) grade for strength, Ashworth tone scale and functional imaging was used for assessments at baseline, 8 weeks and 24 weeks. 50-60 million cells in 250 ml saline were infused intravenously over 2-3 h.
  
  
  RESULTS
  The safety test profile was normal with no mortality or cell related adverse reactions in stem cell patients. Among outcome parameters, only modified Barthel Index (mBI) showed statistical significant improvement (p<0.05) in the stem cell group. An increased number of cluster activation in Brodmann areas BA 4, BA 6 was observed post stem cell infusion indicating neural plasticity.
  
  
  CONCLUSIONS
  Autologous intravenous stem cell therapy is safe and feasible. Stem cells act as "scaffolds" for neural transplantation and may aid in repair mechanisms in stroke.
authors.affiliation: Department of Neurology, All India Institute of Medical Sciences, New Delhi 110029, India. ashu.bhasin@gmail.com
authors.forename: Ashu
authors.initials: A
authors.lastname: Bhasin
authors.forename: M V Padma
authors.initials: MV
authors.lastname: Srivastava
authors.forename: Sujata
authors.initials: S
authors.lastname: Mohanty
authors.forename: Rohit
authors.initials: R
authors.lastname: Bhatia
authors.forename: Senthil S
authors.initials: SS
authors.lastname: Kumaran
authors.forename: Sushmita
authors.initials: S
authors.lastname: Bose
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D016026:Bone Marrow Transplantation / Q000009:adverse effects / Q000379:methods; D056324:Diffusion Tensor Imaging; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods; D008875:Middle Aged; D009000:Monocytes / Q000637:transplantation; D009473:Neuronal Plasticity / Q000502:physiology; D010100:Oxygen / Q000097:blood; D026741:Physical Therapy Modalities; D044968:Regenerative Medicine; D033581:Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D020521:Stroke / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010100:Oxygen