Intravenous Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke: Phase1/2a Clinical Trial in a Homogeneous Group of Stroke Patients

Akihiko Taguchi, Chiaki Sakai, Toshihiro Soma, Yukiko Kasahara, David Stern, Katsufumi Kajimoto, Masafumi Ihara, Takashi Daimon, Kenichi Yamahara, Kaori Doi, Nobuo Kohara, Hiroyuki Nishimura, Tomohiro Matsuyama, Hiroaki Naritomi, Nobuyuki Sakai, Kazuyuki Nagatsuka

Research output: Contribution to journalArticle

42 Citations (Scopus)

Abstract

The goal of this clinical trial was to assess the feasibility and safety of transplanting autologous bone marrow mononuclear cells into patients suffering severe embolic stroke. Major inclusion criteria included patients with cerebral embolism, age 20-75 years, National Institute of Health Stroke Scale (NIHSS) score displaying improvement of ≤5 points during the first 7 days after stroke, and NIHSS score of ≥10 on day 7 after stroke. Bone marrow aspiration (25 or 50mL; N=6 patients in each case) was performed 7-10 days poststroke, and bone marrow mononuclear cells were administrated intravenously. Mean total transplanted cell numbers were 2.5×108 and 3.4×108 cells in the lower and higher dose groups, respectively. No apparent adverse effects of administering bone marrow cells were observed. Compared with the lower dose, patients receiving the higher dose of bone marrow cells displayed a trend toward improved neurologic outcomes. Compared with 1 month after treatment, patients receiving cell therapy displayed a trend toward improved cerebral blood flow and metabolic rate of oxygen consumption 6 months after treatment. In comparison with historical controls, patients receiving cell therapy had significantly better neurologic outcomes. Our results indicated that intravenous transplantation of autologous bone marrow mononuclear cells is safe and feasible. Positive results and trends favoring neurologic recovery and improvement in cerebral blood flow and metabolism by cell therapy underscore the relevance of larger scale randomized controlled trials using this approach.

Original languageEnglish (US)
Pages (from-to)2207-2218
Number of pages12
JournalStem Cells and Development
Volume24
Issue number19
DOIs
StatePublished - Jan 1 2015

Fingerprint

Bone Marrow Transplantation
Bone Marrow Cells
Stroke
Clinical Trials
Cerebrovascular Circulation
Cell- and Tissue-Based Therapy
Nervous System
National Institutes of Health (U.S.)
Intracranial Embolism
Autologous Transplantation
Oxygen Consumption
Randomized Controlled Trials
Cell Count
Bone Marrow
Safety
Therapeutics

All Science Journal Classification (ASJC) codes

  • Hematology
  • Developmental Biology
  • Cell Biology

Cite this

Intravenous Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke : Phase1/2a Clinical Trial in a Homogeneous Group of Stroke Patients. / Taguchi, Akihiko; Sakai, Chiaki; Soma, Toshihiro; Kasahara, Yukiko; Stern, David; Kajimoto, Katsufumi; Ihara, Masafumi; Daimon, Takashi; Yamahara, Kenichi; Doi, Kaori; Kohara, Nobuo; Nishimura, Hiroyuki; Matsuyama, Tomohiro; Naritomi, Hiroaki; Sakai, Nobuyuki; Nagatsuka, Kazuyuki.

In: Stem Cells and Development, Vol. 24, No. 19, 01.01.2015, p. 2207-2218.

Research output: Contribution to journalArticle

Taguchi, A, Sakai, C, Soma, T, Kasahara, Y, Stern, D, Kajimoto, K, Ihara, M, Daimon, T, Yamahara, K, Doi, K, Kohara, N, Nishimura, H, Matsuyama, T, Naritomi, H, Sakai, N & Nagatsuka, K 2015, 'Intravenous Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke: Phase1/2a Clinical Trial in a Homogeneous Group of Stroke Patients', Stem Cells and Development, vol. 24, no. 19, pp. 2207-2218. https://doi.org/10.1089/scd.2015.0160
Taguchi, Akihiko ; Sakai, Chiaki ; Soma, Toshihiro ; Kasahara, Yukiko ; Stern, David ; Kajimoto, Katsufumi ; Ihara, Masafumi ; Daimon, Takashi ; Yamahara, Kenichi ; Doi, Kaori ; Kohara, Nobuo ; Nishimura, Hiroyuki ; Matsuyama, Tomohiro ; Naritomi, Hiroaki ; Sakai, Nobuyuki ; Nagatsuka, Kazuyuki. / Intravenous Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke : Phase1/2a Clinical Trial in a Homogeneous Group of Stroke Patients. In: Stem Cells and Development. 2015 ; Vol. 24, No. 19. pp. 2207-2218.
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