Short and Long Term Clinical and Immunologic Follow up after Bone Marrow Mesenchymal Stromal Cell Therapy in Progressive Multiple Sclerosis—A Phase I Study

Iacobaeus, Ellen; Kadri, Nadir; Lefsihane, Katia; Boberg, Erik; Gavin, Caroline; Törnqvist Andrén, Anton; Lilja, Anders; Brundin, Lou; Blanc, Katarina Le

doi:10.3390/jcm8122102

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Short and Long Term Clinical and Immunologic Follow up after Bone Marrow Mesenchymal Stromal Cell Therapy in Progressive Multiple Sclerosis—A Phase I Study

^1,2,*,†,

^1,†,

¹,

¹,

¹,

Anton Törnqvist Andrén

¹,

Anders Lilja

³,

Lou Brundin

² and

Katarina Le Blanc

^1,4

Department of Laboratory Medicine, Division of Clinical Immunology, Karolinska Institute, 141 52 Stockholm, Sweden

Department of Clinical Neuroscience, Division of Neurology, Karolinska Institute, 171 64 Stockholm, Sweden

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)

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Abstract

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. View Full-Text

Keywords: clinical trial; cell- and tissue-based therapy; mesenchymal stromal cells; multiple sclerosis; chronic progressive; autoimmune disease

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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. https://doi.org/10.3390/jcm8122102

AMA Style

Iacobaeus E, Kadri N, Lefsihane K, Boberg E, Gavin C, Törnqvist Andrén A, Lilja A, Brundin L, Blanc KL. Short and Long Term Clinical and Immunologic Follow up after Bone Marrow Mesenchymal Stromal Cell Therapy in Progressive Multiple Sclerosis—A Phase I Study. Journal of Clinical Medicine. 2019; 8(12):2102. https://doi.org/10.3390/jcm8122102

Chicago/Turabian Style

Iacobaeus, Ellen, Nadir Kadri, Katia Lefsihane, Erik Boberg, Caroline Gavin, Anton Törnqvist Andrén, Anders Lilja, Lou Brundin, and Katarina L. Blanc. 2019. "Short and Long Term Clinical and Immunologic Follow up after Bone Marrow Mesenchymal Stromal Cell Therapy in Progressive Multiple Sclerosis—A Phase I Study" Journal of Clinical Medicine 8, no. 12: 2102. https://doi.org/10.3390/jcm8122102

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Short and Long Term Clinical and Immunologic Follow up after Bone Marrow Mesenchymal Stromal Cell Therapy in Progressive Multiple Sclerosis—A Phase I Study

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