Short and Long Term Clinical and Immunologic Follow up after Bone Marrow Mesenchymal Stromal Cell Therapy in Progressive Multiple Sclerosis—A Phase I Study
by
Ellen Iacobaeus 1,2,*,†, Nadir Kadri 1,†, Katia Lefsihane 1, Erik Boberg 1, Caroline Gavin 1, Anton Törnqvist Andrén 1, Anders Lilja 3, Lou Brundin 2 and Katarina Le Blanc 1,4
Ellen Iacobaeus 1,2,*,†, Nadir Kadri 1,†, Katia Lefsihane 1, Erik Boberg 1, Caroline Gavin 1, Anton Törnqvist Andrén 1, Anders Lilja 3, Lou Brundin 2 and Katarina Le Blanc 1,4
1
Department of Laboratory Medicine, Division of Clinical Immunology, Karolinska Institute, 141 52 Stockholm, Sweden
2
Department of Clinical Neuroscience, Division of Neurology, Karolinska Institute, 171 64 Stockholm, Sweden
3
Department of Clinical Neuroscience, Section of Neuroradiology, Karolinska Institute, 171 64 Stockholm, Sweden
4
Center for Haematology and CAST, Karolinska University Hospital Huddinge, 141 57 Stockholm, Sweden
*
Author to whom correspondence should be addressed.
†
These authors contributed equally to this work.
J. Clin. Med. 2019, 8(12), 2102; https://doi.org/10.3390/jcm8122102
Received: 21 October 2019 / Revised: 20 November 2019 / Accepted: 21 November 2019 / Published: 2 December 2019
(This article belongs to the Special Issue Mesenchymal Stem/Stromal Cells in Immunity and Disease)
Bone marrow derived mesenchymal stromal cells (BM-MSCs) have emerged as a possible new therapy for Multiple Sclerosis (MS), however studies regarding efficacy and in vivo immune response have been limited and inconclusive. We conducted a phase I clinical study assessing safety and clinical and peripheral immune responses after MSC therapy in MS. Seven patients with progressive MS were intravenously infused with a single dose of autologous MSC (1–2 × 106 MSCs/kg body weight). The infusions were safe and well tolerated when given during clinical remission. Five out of seven patients completed the follow up of 48 weeks post-infusion. Brain magnetic resonance imaging (MRI) showed the absence of new T2 lesions at 12 weeks in 5/6 patients, while 3/5 had accumulated new T2 lesions at 48 weeks. Patient expanded disability status scales (EDSS) were stable in 6/6 at 12 weeks but declined in 3/5 patients at 48 weeks. Early changes of circulating microRNA levels (2 h) and increased proportion of FOXP3+ Tregs were detected at 7 days post-infusion compared to baseline levels. In conclusion, MSC therapy was safe and well tolerated and is associated with possible transient beneficial clinical and peripheral immunotolerogenic effects.
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Keywords:
clinical trial; cell- and tissue-based therapy; mesenchymal stromal cells; multiple sclerosis; chronic progressive; autoimmune disease
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MDPI and ACS Style
Iacobaeus, E.; Kadri, N.; Lefsihane, K.; Boberg, E.; Gavin, C.; Törnqvist Andrén, A.; Lilja, A.; Brundin, L.; Blanc, K.L. Short and Long Term Clinical and Immunologic Follow up after Bone Marrow Mesenchymal Stromal Cell Therapy in Progressive Multiple Sclerosis—A Phase I Study. J. Clin. Med. 2019, 8, 2102.
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