Intracerebral transplantation of autologous adipose‐derived stem cells for chronic ischemic stroke: A phase I study
| Autor: | Horng-Jyh Harn, Sheng-Tzung Tsai, Tsung-Lang Chiu, Shinn Zong Lin, Chuang Ming-Hsi, Po-Cheng Lin, Chih Yang Huang, Yi-Fen Wang, Chun-Hung Chen, Pi Chun Huang, Rathinasamy Baskaran, Wan-Sin Syu, Yi-Chun Lin, Chuang Chi-Hsuan |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Biomedical Engineering Medicine (miscellaneous) Adipose tissue Mesenchymal Stem Cell Transplantation Transplantation Autologous Biomaterials Cell therapy Internal medicine medicine Humans Adverse effect Stroke Ischemic Stroke medicine.diagnostic_test business.industry Magnetic resonance imaging medicine.disease Clinical trial Treatment Outcome Adipose Tissue Berg Balance Scale Cardiology Stem cell business |
| Zdroj: | Journal of Tissue Engineering and Regenerative Medicine. 16:3-13 |
| ISSN: | 1932-7005 1932-6254 |
| DOI: | 10.1002/term.3256 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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