Phase I Trial of Repeated Intrathecal Autologous Bone Marrow‐Derived Mesenchymal Stromal Cells in Amyotrophic Lateral Sclerosis
The aim of this open‐label phase I clinical trial is to evaluate the safety of two repeated intrathecal injections of autologous bone marrow (BM)‐derived mesenchymal stromal cells (MSCs) in amyotrophic lateral sclerosis patients. With the exception of 1 patient who died before the bone marrow extrac...
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Published in | Stem cells translational medicine Vol. 4; no. 6; pp. 590 - 597 |
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Main Authors | , , , , , , , , |
Format | Journal Article |
Language | English |
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Durham, NC, USA
AlphaMed Press
01.06.2015
Oxford University Press |
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Abstract | The aim of this open‐label phase I clinical trial is to evaluate the safety of two repeated intrathecal injections of autologous bone marrow (BM)‐derived mesenchymal stromal cells (MSCs) in amyotrophic lateral sclerosis patients. With the exception of 1 patient who died before the bone marrow extraction, no serious adverse events were observed during the follow‐up period. Two repeated intrathecal injections of autologous MSCs were safe and feasible throughout the duration of the 12‐month follow‐up period.
Stem cell therapy is an emerging alternative therapeutic or disease‐modifying strategy for amyotrophic lateral sclerosis (ALS). The aim of this open‐label phase I clinical trial was to evaluate the safety of two repeated intrathecal injections of autologous bone marrow (BM)‐derived mesenchymal stromal cells (MSCs) in ALS patients. Eight patients with definite or probable ALS were enrolled. After a 3‐month lead‐in period, autologous MSCs were isolated two times from the BM at an interval of 26 days and were then expanded in vitro for 28 days and suspended in autologous cerebrospinal fluid. Of the 8 patients, 7 received 2 intrathecal injections of autologous MSCs (1 × 106 cells per kg) 26 days apart. Clinical or laboratory measurements were recorded to evaluate the safety 12 months after the first MSC injection. The ALS Functional Rating Scale‐Revised (ALSFRS‐R), the Appel ALS score, and forced vital capacity were used to evaluate the patients' disease status. One patient died before treatment and was withdrawn from the study. With the exception of that patient, no serious adverse events were observed during the 12‐month follow‐up period. Most of the adverse events were self‐limited or subsided after supportive treatment within 4 days. Decline in the ALSFRS‐R score was not accelerated during the 6‐month follow‐up period. Two repeated intrathecal injections of autologous MSCs were safe and feasible throughout the duration of the 12‐month follow‐up period.
Significance
Stem cell therapy is an emerging alternative therapeutic or disease‐modifying strategy for amyotrophic lateral sclerosis (ALS). To the authors' best knowledge, there are no clinical trials to evaluate the safety of repeated intrathecal injections of autologous bone marrow mesenchymal stromal cells in ALS. After the clinical trial (phase I/II) was conducted, the stem cell (HYNR‐CS, NEURONATA‐R) was included in the revision of the regulations on orphan drug designation (number 160; December 31, 2013) and approved as a New Drug Application (Department of Cell and Gene Therapy 233; July 30, 2014) by the Korean Food and Drug Administration. The phase II trial is expected to be reported later. |
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AbstractList | Abstract
Stem cell therapy is an emerging alternative therapeutic or disease-modifying strategy for amyotrophic lateral sclerosis (ALS). The aim of this open-label phase I clinical trial was to evaluate the safety of two repeated intrathecal injections of autologous bone marrow (BM)-derived mesenchymal stromal cells (MSCs) in ALS patients. Eight patients with definite or probable ALS were enrolled. After a 3-month lead-in period, autologous MSCs were isolated two times from the BM at an interval of 26 days and were then expanded in vitro for 28 days and suspended in autologous cerebrospinal fluid. Of the 8 patients, 7 received 2 intrathecal injections of autologous MSCs (1 × 106 cells per kg) 26 days apart. Clinical or laboratory measurements were recorded to evaluate the safety 12 months after the first MSC injection. The ALS Functional Rating Scale-Revised (ALSFRS-R), the Appel ALS score, and forced vital capacity were used to evaluate the patients' disease status. One patient died before treatment and was withdrawn from the study. With the exception of that patient, no serious adverse events were observed during the 12-month follow-up period. Most of the adverse events were self-limited or subsided after supportive treatment within 4 days. Decline in the ALSFRS-R score was not accelerated during the 6-month follow-up period. Two repeated intrathecal injections of autologous MSCs were safe and feasible throughout the duration of the 12-month follow-up period.
Significance
Stem cell therapy is an emerging alternative therapeutic or disease-modifying strategy for amyotrophic lateral sclerosis (ALS). To the authors' best knowledge, there are no clinical trials to evaluate the safety of repeated intrathecal injections of autologous bone marrow mesenchymal stromal cells in ALS. After the clinical trial (phase I/II) was conducted, the stem cell (HYNR-CS, NEURONATA-R) was included in the revision of the regulations on orphan drug designation (number 160; December 31, 2013) and approved as a New Drug Application (Department of Cell and Gene Therapy 233; July 30, 2014) by the Korean Food and Drug Administration. The phase II trial is expected to be reported later. Stem cell therapy is an emerging alternative therapeutic or disease-modifying strategy for amyotrophic lateral sclerosis (ALS). The aim of this open-label phase I clinical trial was to evaluate the safety of two repeated intrathecal injections of autologous bone marrow (BM)-derived mesenchymal stromal cells (MSCs) in ALS patients. Eight patients with definite or probable ALS were enrolled. After a 3-month lead-in period, autologous MSCs were isolated two times from the BM at an interval of 26 days and were then expanded in vitro for 28 days and suspended in autologous cerebrospinal fluid. Of the 8 patients, 7 received 2 intrathecal injections of autologous MSCs (1 × 10(6) cells per kg) 26 days apart. Clinical or laboratory measurements were recorded to evaluate the safety 12 months after the first MSC injection. The ALS Functional Rating Scale-Revised (ALSFRS-R), the Appel ALS score, and forced vital capacity were used to evaluate the patients' disease status. One patient died before treatment and was withdrawn from the study. With the exception of that patient, no serious adverse events were observed during the 12-month follow-up period. Most of the adverse events were self-limited or subsided after supportive treatment within 4 days. Decline in the ALSFRS-R score was not accelerated during the 6-month follow-up period. Two repeated intrathecal injections of autologous MSCs were safe and feasible throughout the duration of the 12-month follow-up period. Stem cell therapy is an emerging alternative therapeutic or disease-modifying strategy for amyotrophic lateral sclerosis (ALS). To the authors' best knowledge, there are no clinical trials to evaluate the safety of repeated intrathecal injections of autologous bone marrow mesenchymal stromal cells in ALS. After the clinical trial (phase I/II) was conducted, the stem cell (HYNR-CS, NEURONATA-R) was included in the revision of the regulations on orphan drug designation (number 160; December 31, 2013) and approved as a New Drug Application (Department of Cell and Gene Therapy 233; July 30, 2014) by the Korean Food and Drug Administration. The phase II trial is expected to be reported later. The aim of this open-label phase I clinical trial is to evaluate the safety of two repeated intrathecal injections of autologous bone marrow (BM)-derived mesenchymal stromal cells (MSCs) in amyotrophic lateral sclerosis patients. With the exception of 1 patient who died before the bone marrow extraction, no serious adverse events were observed during the follow-up period. Two repeated intrathecal injections of autologous MSCs were safe and feasible throughout the duration of the 12-month follow-up period. The aim of this open‐label phase I clinical trial is to evaluate the safety of two repeated intrathecal injections of autologous bone marrow (BM)‐derived mesenchymal stromal cells (MSCs) in amyotrophic lateral sclerosis patients. With the exception of 1 patient who died before the bone marrow extraction, no serious adverse events were observed during the follow‐up period. Two repeated intrathecal injections of autologous MSCs were safe and feasible throughout the duration of the 12‐month follow‐up period. Stem cell therapy is an emerging alternative therapeutic or disease‐modifying strategy for amyotrophic lateral sclerosis (ALS). The aim of this open‐label phase I clinical trial was to evaluate the safety of two repeated intrathecal injections of autologous bone marrow (BM)‐derived mesenchymal stromal cells (MSCs) in ALS patients. Eight patients with definite or probable ALS were enrolled. After a 3‐month lead‐in period, autologous MSCs were isolated two times from the BM at an interval of 26 days and were then expanded in vitro for 28 days and suspended in autologous cerebrospinal fluid. Of the 8 patients, 7 received 2 intrathecal injections of autologous MSCs (1 × 106 cells per kg) 26 days apart. Clinical or laboratory measurements were recorded to evaluate the safety 12 months after the first MSC injection. The ALS Functional Rating Scale‐Revised (ALSFRS‐R), the Appel ALS score, and forced vital capacity were used to evaluate the patients' disease status. One patient died before treatment and was withdrawn from the study. With the exception of that patient, no serious adverse events were observed during the 12‐month follow‐up period. Most of the adverse events were self‐limited or subsided after supportive treatment within 4 days. Decline in the ALSFRS‐R score was not accelerated during the 6‐month follow‐up period. Two repeated intrathecal injections of autologous MSCs were safe and feasible throughout the duration of the 12‐month follow‐up period. Significance Stem cell therapy is an emerging alternative therapeutic or disease‐modifying strategy for amyotrophic lateral sclerosis (ALS). To the authors' best knowledge, there are no clinical trials to evaluate the safety of repeated intrathecal injections of autologous bone marrow mesenchymal stromal cells in ALS. After the clinical trial (phase I/II) was conducted, the stem cell (HYNR‐CS, NEURONATA‐R) was included in the revision of the regulations on orphan drug designation (number 160; December 31, 2013) and approved as a New Drug Application (Department of Cell and Gene Therapy 233; July 30, 2014) by the Korean Food and Drug Administration. The phase II trial is expected to be reported later. Stem cell therapy is an emerging alternative therapeutic or disease-modifying strategy for amyotrophic lateral sclerosis (ALS). The aim of this open-label phase I clinical trial was to evaluate the safety of two repeated intrathecal injections of autologous bone marrow (BM)-derived mesenchymal stromal cells (MSCs) in ALS patients. Eight patients with definite or probable ALS were enrolled. After a 3-month lead-in period, autologous MSCs were isolated two times from the BM at an interval of 26 days and were then expanded in vitro for 28 days and suspended in autologous cerebrospinal fluid. Of the 8 patients, 7 received 2 intrathecal injections of autologous MSCs (1 x 10 super(6) cells per kg) 26 days apart. Clinical or laboratory measurements were recorded to evaluate the safety 12 months after the first MSC injection. The ALS Functional Rating Scale-Revised (ALSFRS-R), the Appel ALS score, and forced vital capacity were used to evaluate the patients' disease status. One patient died before treatment and was withdrawn from the study. With the exception of that patient, no serious adverse events were observed during the 12-month follow-up period. Most of the adverse events were self-limited or subsided after supportive treatment within 4 days. Decline in the ALSFRS-R score was not accelerated during the 6-month follow-up period. Two repeated intrathecal injections of autologous MSCs were safe and feasible throughout the duration of the 12-month follow-up period. UNLABELLEDStem cell therapy is an emerging alternative therapeutic or disease-modifying strategy for amyotrophic lateral sclerosis (ALS). The aim of this open-label phase I clinical trial was to evaluate the safety of two repeated intrathecal injections of autologous bone marrow (BM)-derived mesenchymal stromal cells (MSCs) in ALS patients. Eight patients with definite or probable ALS were enrolled. After a 3-month lead-in period, autologous MSCs were isolated two times from the BM at an interval of 26 days and were then expanded in vitro for 28 days and suspended in autologous cerebrospinal fluid. Of the 8 patients, 7 received 2 intrathecal injections of autologous MSCs (1 × 10(6) cells per kg) 26 days apart. Clinical or laboratory measurements were recorded to evaluate the safety 12 months after the first MSC injection. The ALS Functional Rating Scale-Revised (ALSFRS-R), the Appel ALS score, and forced vital capacity were used to evaluate the patients' disease status. One patient died before treatment and was withdrawn from the study. With the exception of that patient, no serious adverse events were observed during the 12-month follow-up period. Most of the adverse events were self-limited or subsided after supportive treatment within 4 days. Decline in the ALSFRS-R score was not accelerated during the 6-month follow-up period. Two repeated intrathecal injections of autologous MSCs were safe and feasible throughout the duration of the 12-month follow-up period.SIGNIFICANCEStem cell therapy is an emerging alternative therapeutic or disease-modifying strategy for amyotrophic lateral sclerosis (ALS). To the authors' best knowledge, there are no clinical trials to evaluate the safety of repeated intrathecal injections of autologous bone marrow mesenchymal stromal cells in ALS. After the clinical trial (phase I/II) was conducted, the stem cell (HYNR-CS, NEURONATA-R) was included in the revision of the regulations on orphan drug designation (number 160; December 31, 2013) and approved as a New Drug Application (Department of Cell and Gene Therapy 233; July 30, 2014) by the Korean Food and Drug Administration. The phase II trial is expected to be reported later. |
Author | Kim, Hyun Young Oh, Ki-Wook Oh, Sung-il Moon, Chanil Kim, Seung Hyun Lee, Jun Ho Kim, Kyung Suk Park, Jinseok Chang, In Young |
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BackLink | https://www.ncbi.nlm.nih.gov/pubmed/25934946$$D View this record in MEDLINE/PubMed |
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ParticipantIDs | pubmedcentral_primary_oai_pubmedcentral_nih_gov_4449093 proquest_miscellaneous_1859475141 proquest_miscellaneous_1685745215 proquest_journals_2299130533 crossref_primary_10_5966_sctm_2014_0212 pubmed_primary_25934946 wiley_primary_10_5966_sctm_2014_0212_SCT3201546590 |
PublicationCentury | 2000 |
PublicationDate | June 2015 |
PublicationDateYYYYMMDD | 2015-06-01 |
PublicationDate_xml | – month: 06 year: 2015 text: June 2015 |
PublicationDecade | 2010 |
PublicationPlace | Durham, NC, USA |
PublicationPlace_xml | – name: Durham, NC, USA – name: United States – name: Oxford |
PublicationTitle | Stem cells translational medicine |
PublicationTitleAlternate | Stem Cells Transl Med |
PublicationYear | 2015 |
Publisher | AlphaMed Press Oxford University Press |
Publisher_xml | – name: AlphaMed Press – name: Oxford University Press |
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Snippet | The aim of this open‐label phase I clinical trial is to evaluate the safety of two repeated intrathecal injections of autologous bone marrow (BM)‐derived... Stem cell therapy is an emerging alternative therapeutic or disease-modifying strategy for amyotrophic lateral sclerosis (ALS). The aim of this open-label... Abstract Stem cell therapy is an emerging alternative therapeutic or disease-modifying strategy for amyotrophic lateral sclerosis (ALS). The aim of this... The aim of this open-label phase I clinical trial is to evaluate the safety of two repeated intrathecal injections of autologous bone marrow (BM)-derived... UNLABELLEDStem cell therapy is an emerging alternative therapeutic or disease-modifying strategy for amyotrophic lateral sclerosis (ALS). The aim of this... |
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SubjectTerms | Administrative support Adult Aged Amyotrophic lateral sclerosis Amyotrophic Lateral Sclerosis - physiopathology Amyotrophic Lateral Sclerosis - therapy Autografts Bone marrow Bone Marrow Cells Cell-Based Drug Development, Screening, and Toxicology Clinical trials Data analysis Drug dosages FDA approval Female Follow-Up Studies Humans Intrathecal Male Mesenchymal Stem Cell Transplantation Mesenchymal stem cells Mesenchymal Stromal Cells Mesenchyme Middle Aged Patients Spinal cord Stem cells Stromal cells Studies |
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Title | Phase I Trial of Repeated Intrathecal Autologous Bone Marrow‐Derived Mesenchymal Stromal Cells in Amyotrophic Lateral Sclerosis |
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