Intravenous Infusion of Umbilical Cord Blood‐Derived Mesenchymal Stem Cells in Rheumatoid Arthritis: A Phase Ia Clinical Trial
Based on immunomodulatory actions of human umbilical cord blood‐derived mesenchymal stem cells (hUCB‐MSCs), in vitro or preclinical studies of hUCB‐MSCs have been conducted extensively in rheumatoid arthritis (RA). However, few human trials have investigated the outcomes of hUCB‐MSC infusions. The C...
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| Published in: | Stem cells translational medicine Vol. 7; no. 9; pp. 636 - 642 |
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| Main Authors: | , , , , , , |
| Format: | Journal Article |
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Hoboken, USA
John Wiley & Sons, Inc
01-09-2018
Oxford University Press |
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| Abstract | Based on immunomodulatory actions of human umbilical cord blood‐derived mesenchymal stem cells (hUCB‐MSCs), in vitro or preclinical studies of hUCB‐MSCs have been conducted extensively in rheumatoid arthritis (RA). However, few human trials have investigated the outcomes of hUCB‐MSC infusions. The CURE‐iv trial was a phase I, uncontrolled, open label trial for RA patients with moderate disease activity despite treatment with methotrexate. The patients received a single intravenous infusion of 2.5 × 107, 5 × 107, or 1 × 108 cells of hUCB‐MSCs for 30 minutes, three patients in each cluster, with an increment of cell numbers when there was no dose‐limited adverse event. Clinical and safety assessments were performed during the study period, and serum cytokines were measured at baseline and 24 hours after the infusion. Out of 11 screened RA patients, 9 were enrolled. The participants were predominantly female (78%) and the mean age was 57.4 years. The mean disease duration was 9.5 years, and baseline 28‐joint disease activity score (DAS28; using erythrocyte sedimentation rate) was 4.53. There was no major toxicity in all clusters up to 4 weeks after the infusion. Serum erythrocyte sedimentation rate changes at 4 weeks (n = 9) were −7.9 ± 10.4 (p = .0517) and DAS28 changes were −1.60 ± 1.57 (p = .0159). Reduced levels of IL‐1β, IL‐6, IL‐8, and TNF‐α at 24 hours were observed in the cluster infused with 1 × 108 MSCs. This phase Ia hUCB‐MSC infusion trial for established RA patients revealed no short‐term safety concerns. Stem Cells Translational Medicine 2018
This is a phase Ia clinical trial to asses the safety of human umbilical cord blood‐derived mesenchyaml stem cells (hUCB‐MSCs) infusions in patients with rheumatoid arthritis (RA). Nine patients with RA were given a single infusion of hUCB‐MSCs, cell numbers up to 1 × 108, and no ominous short‐term safety signal was observed. |
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| AbstractList | Based on immunomodulatory actions of human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs), in vitro or preclinical studies of hUCB-MSCs have been conducted extensively in rheumatoid arthritis (RA). However, few human trials have investigated the outcomes of hUCB-MSC infusions. The CURE-iv trial was a phase I, uncontrolled, open label trial for RA patients with moderate disease activity despite treatment with methotrexate. The patients received a single intravenous infusion of 2.5 × 107, 5 × 107, or 1 × 108 cells of hUCB-MSCs for 30 minutes, three patients in each cluster, with an increment of cell numbers when there was no dose-limited adverse event. Clinical and safety assessments were performed during the study period, and serum cytokines were measured at baseline and 24 hours after the infusion. Out of 11 screened RA patients, 9 were enrolled. The participants were predominantly female (78%) and the mean age was 57.4 years. The mean disease duration was 9.5 years, and baseline 28-joint disease activity score (DAS28; using erythrocyte sedimentation rate) was 4.53. There was no major toxicity in all clusters up to 4 weeks after the infusion. Serum erythrocyte sedimentation rate changes at 4 weeks (n = 9) were −7.9 ± 10.4 (p = .0517) and DAS28 changes were −1.60 ± 1.57 (p = .0159). Reduced levels of IL-1β, IL-6, IL-8, and TNF-α at 24 hours were observed in the cluster infused with 1 × 108 MSCs. This phase Ia hUCB-MSC infusion trial for established RA patients revealed no short-term safety concerns. Based on immunomodulatory actions of human umbilical cord blood‐derived mesenchymal stem cells (hUCB‐MSCs), in vitro or preclinical studies of hUCB‐MSCs have been conducted extensively in rheumatoid arthritis (RA). However, few human trials have investigated the outcomes of hUCB‐MSC infusions. The CURE‐iv trial was a phase I, uncontrolled, open label trial for RA patients with moderate disease activity despite treatment with methotrexate. The patients received a single intravenous infusion of 2.5 × 107, 5 × 107, or 1 × 108 cells of hUCB‐MSCs for 30 minutes, three patients in each cluster, with an increment of cell numbers when there was no dose‐limited adverse event. Clinical and safety assessments were performed during the study period, and serum cytokines were measured at baseline and 24 hours after the infusion. Out of 11 screened RA patients, 9 were enrolled. The participants were predominantly female (78%) and the mean age was 57.4 years. The mean disease duration was 9.5 years, and baseline 28‐joint disease activity score (DAS28; using erythrocyte sedimentation rate) was 4.53. There was no major toxicity in all clusters up to 4 weeks after the infusion. Serum erythrocyte sedimentation rate changes at 4 weeks (n = 9) were −7.9 ± 10.4 (p = .0517) and DAS28 changes were −1.60 ± 1.57 (p = .0159). Reduced levels of IL‐1β, IL‐6, IL‐8, and TNF‐α at 24 hours were observed in the cluster infused with 1 × 108 MSCs. This phase Ia hUCB‐MSC infusion trial for established RA patients revealed no short‐term safety concerns. Stem Cells Translational Medicine 2018 Based on immunomodulatory actions of human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs), in vitro or preclinical studies of hUCB-MSCs have been conducted extensively in rheumatoid arthritis (RA). However, few human trials have investigated the outcomes of hUCB-MSC infusions. The CURE-iv trial was a phase I, uncontrolled, open label trial for RA patients with moderate disease activity despite treatment with methotrexate. The patients received a single intravenous infusion of 2.5 × 10 , 5 × 10 , or 1 × 10 cells of hUCB-MSCs for 30 minutes, three patients in each cluster, with an increment of cell numbers when there was no dose-limited adverse event. Clinical and safety assessments were performed during the study period, and serum cytokines were measured at baseline and 24 hours after the infusion. Out of 11 screened RA patients, 9 were enrolled. The participants were predominantly female (78%) and the mean age was 57.4 years. The mean disease duration was 9.5 years, and baseline 28-joint disease activity score (DAS28; using erythrocyte sedimentation rate) was 4.53. There was no major toxicity in all clusters up to 4 weeks after the infusion. Serum erythrocyte sedimentation rate changes at 4 weeks (n = 9) were -7.9 ± 10.4 (p = .0517) and DAS28 changes were -1.60 ± 1.57 (p = .0159). Reduced levels of IL-1β, IL-6, IL-8, and TNF-α at 24 hours were observed in the cluster infused with 1 × 10 MSCs. This phase Ia hUCB-MSC infusion trial for established RA patients revealed no short-term safety concerns. Stem Cells Translational Medicine 2018. Abstract Based on immunomodulatory actions of human umbilical cord blood‐derived mesenchymal stem cells (hUCB‐MSCs), in vitro or preclinical studies of hUCB‐MSCs have been conducted extensively in rheumatoid arthritis (RA). However, few human trials have investigated the outcomes of hUCB‐MSC infusions. The CURE‐iv trial was a phase I, uncontrolled, open label trial for RA patients with moderate disease activity despite treatment with methotrexate. The patients received a single intravenous infusion of 2.5 × 107, 5 × 107, or 1 × 108 cells of hUCB‐MSCs for 30 minutes, three patients in each cluster, with an increment of cell numbers when there was no dose‐limited adverse event. Clinical and safety assessments were performed during the study period, and serum cytokines were measured at baseline and 24 hours after the infusion. Out of 11 screened RA patients, 9 were enrolled. The participants were predominantly female (78%) and the mean age was 57.4 years. The mean disease duration was 9.5 years, and baseline 28‐joint disease activity score (DAS28; using erythrocyte sedimentation rate) was 4.53. There was no major toxicity in all clusters up to 4 weeks after the infusion. Serum erythrocyte sedimentation rate changes at 4 weeks (n = 9) were −7.9 ± 10.4 (p = .0517) and DAS28 changes were −1.60 ± 1.57 (p = .0159). Reduced levels of IL‐1β, IL‐6, IL‐8, and TNF‐α at 24 hours were observed in the cluster infused with 1 × 108 MSCs. This phase Ia hUCB‐MSC infusion trial for established RA patients revealed no short‐term safety concerns. Stem Cells Translational Medicine 2018 Based on immunomodulatory actions of human umbilical cord blood‐derived mesenchymal stem cells (hUCB‐MSCs), in vitro or preclinical studies of hUCB‐MSCs have been conducted extensively in rheumatoid arthritis (RA). However, few human trials have investigated the outcomes of hUCB‐MSC infusions. The CURE‐iv trial was a phase I, uncontrolled, open label trial for RA patients with moderate disease activity despite treatment with methotrexate. The patients received a single intravenous infusion of 2.5 × 107, 5 × 107, or 1 × 108 cells of hUCB‐MSCs for 30 minutes, three patients in each cluster, with an increment of cell numbers when there was no dose‐limited adverse event. Clinical and safety assessments were performed during the study period, and serum cytokines were measured at baseline and 24 hours after the infusion. Out of 11 screened RA patients, 9 were enrolled. The participants were predominantly female (78%) and the mean age was 57.4 years. The mean disease duration was 9.5 years, and baseline 28‐joint disease activity score (DAS28; using erythrocyte sedimentation rate) was 4.53. There was no major toxicity in all clusters up to 4 weeks after the infusion. Serum erythrocyte sedimentation rate changes at 4 weeks (n = 9) were −7.9 ± 10.4 (p = .0517) and DAS28 changes were −1.60 ± 1.57 (p = .0159). Reduced levels of IL‐1β, IL‐6, IL‐8, and TNF‐α at 24 hours were observed in the cluster infused with 1 × 108 MSCs. This phase Ia hUCB‐MSC infusion trial for established RA patients revealed no short‐term safety concerns. Stem Cells Translational Medicine 2018 This is a phase Ia clinical trial to asses the safety of human umbilical cord blood‐derived mesenchyaml stem cells (hUCB‐MSCs) infusions in patients with rheumatoid arthritis (RA). Nine patients with RA were given a single infusion of hUCB‐MSCs, cell numbers up to 1 × 108, and no ominous short‐term safety signal was observed. Based on immunomodulatory actions of human umbilical cord blood‐derived mesenchymal stem cells (hUCB‐MSCs), in vitro or preclinical studies of hUCB‐MSCs have been conducted extensively in rheumatoid arthritis (RA). However, few human trials have investigated the outcomes of hUCB‐MSC infusions. The CURE‐iv trial was a phase I, uncontrolled, open label trial for RA patients with moderate disease activity despite treatment with methotrexate. The patients received a single intravenous infusion of 2.5 × 10 7 , 5 × 10 7 , or 1 × 10 8 cells of hUCB‐MSCs for 30 minutes, three patients in each cluster, with an increment of cell numbers when there was no dose‐limited adverse event. Clinical and safety assessments were performed during the study period, and serum cytokines were measured at baseline and 24 hours after the infusion. Out of 11 screened RA patients, 9 were enrolled. The participants were predominantly female (78%) and the mean age was 57.4 years. The mean disease duration was 9.5 years, and baseline 28‐joint disease activity score (DAS28; using erythrocyte sedimentation rate) was 4.53. There was no major toxicity in all clusters up to 4 weeks after the infusion. Serum erythrocyte sedimentation rate changes at 4 weeks ( n = 9) were −7.9 ± 10.4 ( p = .0517) and DAS28 changes were −1.60 ± 1.57 ( p = .0159). Reduced levels of IL‐1β, IL‐6, IL‐8, and TNF‐α at 24 hours were observed in the cluster infused with 1 × 10 8 MSCs. This phase Ia hUCB‐MSC infusion trial for established RA patients revealed no short‐term safety concerns. S tem C ells T ranslational M edicine 2018 |
| Author | Park, Eun Hye Seo, Kwang‐Won Kang, Kyung‐Sun Lim, Hee‐suk Lee, Seunghee Roh, Kyounghwan Shin, Kichul |
| AuthorAffiliation | 2 Division of Rheumatology, Department of Internal Medicine Seoul Metropolitan Government‐Seoul National University Boramae Medical Center Seoul South Korea 1 Division of Rheumatology, Department of Internal Medicine Seoul National University Hospital Seoul South Korea 3 Institute for Stem cell Regenerative Medicine Kangstem Biotech Seoul South Korea 4 Adult Stem Cell Research Center, College of Veterinary Medicine Seoul National University Seoul South Korea |
| AuthorAffiliation_xml | – name: 3 Institute for Stem cell Regenerative Medicine Kangstem Biotech Seoul South Korea – name: 2 Division of Rheumatology, Department of Internal Medicine Seoul Metropolitan Government‐Seoul National University Boramae Medical Center Seoul South Korea – name: 1 Division of Rheumatology, Department of Internal Medicine Seoul National University Hospital Seoul South Korea – name: 4 Adult Stem Cell Research Center, College of Veterinary Medicine Seoul National University Seoul South Korea |
| Author_xml | – sequence: 1 givenname: Eun Hye surname: Park fullname: Park, Eun Hye organization: Seoul National University Hospital – sequence: 2 givenname: Hee‐suk surname: Lim fullname: Lim, Hee‐suk organization: Seoul Metropolitan Government‐Seoul National University Boramae Medical Center – sequence: 3 givenname: Seunghee surname: Lee fullname: Lee, Seunghee organization: Kangstem Biotech – sequence: 4 givenname: Kyounghwan surname: Roh fullname: Roh, Kyounghwan organization: Kangstem Biotech – sequence: 5 givenname: Kwang‐Won surname: Seo fullname: Seo, Kwang‐Won organization: Kangstem Biotech – sequence: 6 givenname: Kyung‐Sun surname: Kang fullname: Kang, Kyung‐Sun organization: Seoul National University – sequence: 7 givenname: Kichul orcidid: 0000-0002-6749-7598 surname: Shin fullname: Shin, Kichul email: kideb1@snu.ac.kr organization: Seoul Metropolitan Government‐Seoul National University Boramae Medical Center |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30112846$$D View this record in MEDLINE/PubMed |
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| Copyright | 2018 The Authors published by Wiley Periodicals, Inc. on behalf of AlphaMed Press 2018 The Authors Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press. 2018. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2018 The Authors S C T M published by Wiley Periodicals, Inc. on behalf of AlphaMed Press |
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| Snippet | Based on immunomodulatory actions of human umbilical cord blood‐derived mesenchymal stem cells (hUCB‐MSCs), in vitro or preclinical studies of hUCB‐MSCs have... Based on immunomodulatory actions of human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs), in vitro or preclinical studies of hUCB-MSCs have... Abstract Based on immunomodulatory actions of human umbilical cord blood‐derived mesenchymal stem cells (hUCB‐MSCs), in vitro or preclinical studies of... |
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| Title | Intravenous Infusion of Umbilical Cord Blood‐Derived Mesenchymal Stem Cells in Rheumatoid Arthritis: A Phase Ia Clinical Trial |
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