Intracerebral transplantation of autologous adipose-derived stem cells for chronic ischemic stroke: A phase I study.
J Tissue Eng Regen Med
; 16(1): 3-13, 2022 01.
Article
en En
| MEDLINE
| ID: mdl-34644444
ABSTRACT
Current therapy does not provide significant benefits for patients with chronic stroke. Pre-clinical studies suggested that autologous adipose-derived stem cells have benefits for the treatment of chronic stroke. This Phase I open-label study was conducted to demonstrate the safety and efficacy of autologous adipose-derived stem cells (GXNPC1) in chronic stroke. Three patients with chronic stroke were treated with stereotactic implantation of autologous adipose-derived stem cells (1 × 108 cells). The primary endpoints of safety evaluation included adverse events, over a 6 months post-implantation period. The secondary endpoints included improvements in neurological functions. Evolutional change of brain parenchyma was also followed with magnetic resonance imaging (MRI). All three participants improved significantly at 6 months follow-up. The extent of improvement from pre-treatment was National Institutes of Health Stroke Scale improved 5-15 points, Barthel Index 25-50 points, Berg balance scale 0-21 points and Fugl-Meyer modified sensation 3-28 points. All three patients had signal change along the implantation tract on MRI one month after surgery. There is no related safety issue through 6 months observation. Clinical measures of neurological symptoms of these patients with chronic stroke improved at 6 months without adverse effects after implantation of autologous adipose-derived stem cells (GXNPC1), which might be correlated with post-implantation changes on brain MRI. Clinical Trial Registration-URL https//clinicaltrials.gov/ct2/show/NCT02813512?term=ADSC&cond=Stroke&cntry=TW&draw=2&rank=1 Unique identifier NCT02813512.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Accidente Cerebrovascular
/
Trasplante de Células Madre Mesenquimatosas
/
Accidente Cerebrovascular Isquémico
Límite:
Humans
Idioma:
En
Revista:
J Tissue Eng Regen Med
Asunto de la revista:
BIOTECNOLOGIA
/
HISTOLOGIA
Año:
2022
Tipo del documento:
Article