A Study of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and Liberation Therapy (When Associated With CCSVI) in Patients With RRMS
NCT ID: NCT02587806
Last Updated: 2015-10-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE1/PHASE2
Total Enrollment
69 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-02-28
Study Completion Date
2017-02-28
Brief Summary
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STUDY OBJECTIVES:
Primary Objective: Assessment of treatment safety based on incidence of any treatment emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months post treatment.
Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3 months, 6 months and 12 months after treatment based on the following: EDSS and 29-item Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1) Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and gadolinium-enhanced magnetic resonance imaging (MRI).
Primary Objective: Assessment of treatment safety based on incidence of any treatment emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months post treatment.
Secondary objective: Assessment of efficacy at baseline, prior to discharge, 1 month, 3 months, 6 months and 12 months after treatment based on the following: EDSS and 29-item Multiple Sclerosis Impact Scale (MSIS-29), MS Functional Composite (MSFC) consisting of (1) Timed 25-Foot Walk, (2) 9 Hole Peg Test, and (3) Paced Auditory Serial Addition Test and gadolinium-enhanced magnetic resonance imaging (MRI).
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Detailed Description
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STUDY TREATMENT:
Investigational therapy product: Autologous Bone Marrow-Derived Mesenchymal Stem Cells (BM-MNC).
Method of administration and dose: Super selective intravenous administration of 50 million Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and intrathecal administration of BM-MNCs in dose of 100 million along with liberation therapy (when associated with CCSVI).
SAFETY AND EFFICACY EVALUATION:
The proposed study will assess safety and primary and secondary efficacy endpoints after super selective intravenous and intrathecal administration of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) in 69 patients with Relapsing Remitting Multiple Sclerosis.
Safety Evaluation:
Assessment of treatment safety based on incidence of any treatment emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months post treatment.
Efficacy evaluation:
Clinical evaluations, including EDSS and 29-item Multiple Sclerosis Impact Scale (MSIS-29) will be performed at baseline before stem cell mobilization, prior to discharge at 1, 3, 6 and 12 months after stem cell therapy.
The MS Functional Composite (MSFC) consists of the (a) Timed 25-Foot Walk, (b) 9 Hole Peg Test, and (c) Paced Auditory Serial Addition Test will be performed at baseline before stem cell mobilization and at 12 months after stem cell therapy.
Gadolinium enhanced MRI scans of the brain will be performed at baseline before therapy and then 12 months after stem cell therapy. Follow-up scans will be performed on the same type of scanner used at baseline. Scans will be analyzed centrally. The 'baseline MRI scan' will be the reference for brain volume changes.
DATA COLLECTION AND STATISTICAL ANALYSIS:
Descriptive analyses of the adverse events will be performed. Proportion of adverse events at each visit will be calculated using frequency distribution. The frequency, severity, timing and the potential relationship to the intervention will be assessed in order to characterize the safety of the intervention.
The probability of overall event-free survival (as well as progression-free, relapse-free, or MRI event-free survival) at baseline through 1 year will be calculated. The end point of progression is defined as increased Expanded Disability Status Scale (EDSS) score greater than0.5 from baseline. Analyses will be conducted using Kaplan- Meier estimates with Wald-type 90% CIs based on Greenwood's formula for SE.
Descriptive analyses of all primary and secondary efficacy endpoints will be performed using descriptive statistics. Proportion of patients with clinically significant change in this efficacy measurement scales (EDSS, MSIS, MSFC, MSFC-25 foot walking test, MSFC- Nine Hole Peg Test, MSFC- Paced Auditory Serial Addition Test) and change in gadolinium enhancing lesions, new T2 lesions from previous visit will be presented as a proportion.
The percentage of change in brain volume will be calculated from screening and analyzed by end point status at month 12 with an exact Wilcoxon rank sum test using mean scores when the results are identical.The null hypothesis tests whether the median percentage of change in brain volume among participants who met the end point by month 12 is equal to the median of those who have not met the end point by month 12.
Other primary and secondary efficacy endpoints (EDSS, MSIS, MSFC, MSFC-25 foot walking test, MSFC- Nine Hole Peg Test, MSFC- Paced Auditory Serial Addition Test) will be analyzed using a Wilcoxon signed rank test.Change from baseline outcomes for all the endpoints will be calculated for each patient who underwent stem cell transplant as the post transplant value minus the baseline value. The null hypothesis tests whether the median difference from baseline measurement in the values at the month 1, month 3, month 6 and month 12 visits was significantly different from zero,with baseline measurement defined as the screening assessment for the percentage of change in brain volume and the baseline visit for all other end points.
To calculate MSFC, results from each of the 3 components will be transformed into a z score and averaged to yield a composite for each patient at each time point. The z scores that compose the MSFC score will be calculated using the reference population from the National Multiple Sclerosis Society Task Force database.
Investigational therapy product: Autologous Bone Marrow-Derived Mesenchymal Stem Cells (BM-MNC).
Method of administration and dose: Super selective intravenous administration of 50 million Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and intrathecal administration of BM-MNCs in dose of 100 million along with liberation therapy (when associated with CCSVI).
SAFETY AND EFFICACY EVALUATION:
The proposed study will assess safety and primary and secondary efficacy endpoints after super selective intravenous and intrathecal administration of Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) in 69 patients with Relapsing Remitting Multiple Sclerosis.
Safety Evaluation:
Assessment of treatment safety based on incidence of any treatment emergent/treatment associated adverse events prior to discharge and at 1, 3, 6 and 12 months post treatment.
Efficacy evaluation:
Clinical evaluations, including EDSS and 29-item Multiple Sclerosis Impact Scale (MSIS-29) will be performed at baseline before stem cell mobilization, prior to discharge at 1, 3, 6 and 12 months after stem cell therapy.
The MS Functional Composite (MSFC) consists of the (a) Timed 25-Foot Walk, (b) 9 Hole Peg Test, and (c) Paced Auditory Serial Addition Test will be performed at baseline before stem cell mobilization and at 12 months after stem cell therapy.
Gadolinium enhanced MRI scans of the brain will be performed at baseline before therapy and then 12 months after stem cell therapy. Follow-up scans will be performed on the same type of scanner used at baseline. Scans will be analyzed centrally. The 'baseline MRI scan' will be the reference for brain volume changes.
DATA COLLECTION AND STATISTICAL ANALYSIS:
Descriptive analyses of the adverse events will be performed. Proportion of adverse events at each visit will be calculated using frequency distribution. The frequency, severity, timing and the potential relationship to the intervention will be assessed in order to characterize the safety of the intervention.
The probability of overall event-free survival (as well as progression-free, relapse-free, or MRI event-free survival) at baseline through 1 year will be calculated. The end point of progression is defined as increased Expanded Disability Status Scale (EDSS) score greater than0.5 from baseline. Analyses will be conducted using Kaplan- Meier estimates with Wald-type 90% CIs based on Greenwood's formula for SE.
Descriptive analyses of all primary and secondary efficacy endpoints will be performed using descriptive statistics. Proportion of patients with clinically significant change in this efficacy measurement scales (EDSS, MSIS, MSFC, MSFC-25 foot walking test, MSFC- Nine Hole Peg Test, MSFC- Paced Auditory Serial Addition Test) and change in gadolinium enhancing lesions, new T2 lesions from previous visit will be presented as a proportion.
The percentage of change in brain volume will be calculated from screening and analyzed by end point status at month 12 with an exact Wilcoxon rank sum test using mean scores when the results are identical.The null hypothesis tests whether the median percentage of change in brain volume among participants who met the end point by month 12 is equal to the median of those who have not met the end point by month 12.
Other primary and secondary efficacy endpoints (EDSS, MSIS, MSFC, MSFC-25 foot walking test, MSFC- Nine Hole Peg Test, MSFC- Paced Auditory Serial Addition Test) will be analyzed using a Wilcoxon signed rank test.Change from baseline outcomes for all the endpoints will be calculated for each patient who underwent stem cell transplant as the post transplant value minus the baseline value. The null hypothesis tests whether the median difference from baseline measurement in the values at the month 1, month 3, month 6 and month 12 visits was significantly different from zero,with baseline measurement defined as the screening assessment for the percentage of change in brain volume and the baseline visit for all other end points.
To calculate MSFC, results from each of the 3 components will be transformed into a z score and averaged to yield a composite for each patient at each time point. The z scores that compose the MSFC score will be calculated using the reference population from the National Multiple Sclerosis Society Task Force database.
Conditions
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Multiple Sclerosis, Relapsing-Remitting
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC)
Super selective intravenous administration of 50 million Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and intrathecal administration of BM-MNCs in dose of 100 million along with liberation therapy (when associated with CCSVI)
Group Type
EXPERIMENTAL
Autologous Bone Marrow-Derived Mononuclear Stem Cells
Intervention Type
BIOLOGICAL
Super selective intravenous administration of 50 million Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and intrathecal administration of BM-MNCs in dose of 100 million along with liberation therapy (when associated with CCSVI)
Liberation therapy
Intervention Type
OTHER
Interventions
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Autologous Bone Marrow-Derived Mononuclear Stem Cells
Super selective intravenous administration of 50 million Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and intrathecal administration of BM-MNCs in dose of 100 million along with liberation therapy (when associated with CCSVI)
Intervention Type
BIOLOGICAL
Liberation therapy
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Males and Females between age 18 and 60 years
* Diagnosis of Relapsing Remitting Multiple Sclerosis made by a neurology expert/MS expert with lesions demonstrated on brain MRI that are consistent with MS
* Duration of disease: \>5 years
* Having an EDSS (Kurtzke Expanded Disability Status Scale) score between 3.5 \& 6
* History of 2 or more relapses within last 2 years with increase in EDSS scale of \> 0.5 sustained for \> 4 weeks
* Failure to respond or intolerance to the currently available Multiple Sclerosis (MS) immunomodulatory treatments): the lack of response to these treatments will be determined/defined by history of 2 or more relapses within last 2 years with increase in EDSS scale of \> 0.5 sustained for \> 4 weeks
* Must have proof of health insurance in country of residence
* Diagnosis of Relapsing Remitting Multiple Sclerosis made by a neurology expert/MS expert with lesions demonstrated on brain MRI that are consistent with MS
* Duration of disease: \>5 years
* Having an EDSS (Kurtzke Expanded Disability Status Scale) score between 3.5 \& 6
* History of 2 or more relapses within last 2 years with increase in EDSS scale of \> 0.5 sustained for \> 4 weeks
* Failure to respond or intolerance to the currently available Multiple Sclerosis (MS) immunomodulatory treatments): the lack of response to these treatments will be determined/defined by history of 2 or more relapses within last 2 years with increase in EDSS scale of \> 0.5 sustained for \> 4 weeks
* Must have proof of health insurance in country of residence
Exclusion Criteria
* Primary progressive, secondary progressive or progressive relapsing MS as defined by Lublin and Reingold, 1996. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses but are distinguished from relapsing remitting subjects by the lack of clinically stable periods of clinical improvement.
* Unable to perform Timed 25-Foot Walk, 9 Hole Peg Test (HPT) (with both upper extremities) and Paced Auditory Serial Addition Test (PASAT 3)
* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
* Life expectancy \< 6 months due to concomitant illnesses
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease: For patients who have tested positive, an expert will be consulted as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Patients with unstable cardiac status (unstable angina, attack of myocardial infarction within last 6 months, uncontrolled high blood pressure, hypotension, cardiomyopathy)
* Cerebrovascular accident within 6 months prior to study entry
* Patients with poorly controlled diabetes mellitus
* Patients with renal insufficiency (Creatinine\> 2.5) or failure
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator is not suitable to participate.
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years
* Unwilling and/or not able to give written informed consent.
* Unable to perform Timed 25-Foot Walk, 9 Hole Peg Test (HPT) (with both upper extremities) and Paced Auditory Serial Addition Test (PASAT 3)
* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
* Life expectancy \< 6 months due to concomitant illnesses
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease: For patients who have tested positive, an expert will be consulted as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Patients with unstable cardiac status (unstable angina, attack of myocardial infarction within last 6 months, uncontrolled high blood pressure, hypotension, cardiomyopathy)
* Cerebrovascular accident within 6 months prior to study entry
* Patients with poorly controlled diabetes mellitus
* Patients with renal insufficiency (Creatinine\> 2.5) or failure
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator is not suitable to participate.
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years
* Unwilling and/or not able to give written informed consent.
Minimum Eligible Age
18 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Novo Cellular Medicine Institute LLP
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Dr. Bill Brashier, M.D.
Role: PRINCIPAL_INVESTIGATOR
Novo Cellular Medicine Institute LLP
Locations
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Inamdar Multispecialty Hospital
Pune, Maharashtra, India
Site Status
RECRUITING
Novo Cellular Medicine Institute
San Fernando, Trinidad, Trinidad and Tobago
Site Status
RECRUITING
Countries
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India
Trinidad and Tobago
Central Contacts
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Facility Contacts
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References
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Bermel RA, Bakshi R. The measurement and clinical relevance of brain atrophy in multiple sclerosis. Lancet Neurol. 2006 Feb;5(2):158-70. doi: 10.1016/S1474-4422(06)70349-0.
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Coles A. The curious incident of disability in multiple sclerosis trials. Lancet Neurol. 2006 Nov;5(11):899-900. doi: 10.1016/S1474-4422(06)70585-3. No abstract available.
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BACKGROUND
Malgieri A, Kantzari E, Patrizi MP, Gambardella S. Bone marrow and umbilical cord blood human mesenchymal stem cells: state of the art. Int J Clin Exp Med. 2010 Sep 7;3(4):248-69.
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BACKGROUND
Kurtzke JF. Historical and clinical perspectives of the expanded disability status scale. Neuroepidemiology. 2008;31(1):1-9. doi: 10.1159/000136645. Epub 2008 Jun 6.
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BACKGROUND
Rudick R, Antel J, Confavreux C, Cutter G, Ellison G, Fischer J, Lublin F, Miller A, Petkau J, Rao S, Reingold S, Syndulko K, Thompson A, Wallenberg J, Weinshenker B, Willoughby E. Recommendations from the National Multiple Sclerosis Society Clinical Outcomes Assessment Task Force. Ann Neurol. 1997 Sep;42(3):379-82. doi: 10.1002/ana.410420318.
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BACKGROUND
Cutter GR, Baier ML, Rudick RA, Cookfair DL, Fischer JS, Petkau J, Syndulko K, Weinshenker BG, Antel JP, Confavreux C, Ellison GW, Lublin F, Miller AE, Rao SM, Reingold S, Thompson A, Willoughby E. Development of a multiple sclerosis functional composite as a clinical trial outcome measure. Brain. 1999 May;122 ( Pt 5):871-82. doi: 10.1093/brain/122.5.871.
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BACKGROUND
Bonzano L, Roccatagliata L, Mancardi GL, Sormani MP. Gadolinium-enhancing or active T2 magnetic resonance imaging lesions in multiple sclerosis clinical trials? Mult Scler. 2009 Sep;15(9):1043-7. doi: 10.1177/1352458509106610. Epub 2009 Jul 1.
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BACKGROUND
Brex PA, Ciccarelli O, O'Riordan JI, Sailer M, Thompson AJ, Miller DH. A longitudinal study of abnormalities on MRI and disability from multiple sclerosis. N Engl J Med. 2002 Jan 17;346(3):158-64. doi: 10.1056/NEJMoa011341.
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BACKGROUND
O'Riordan JI, Gawne Cain M, Coles A, Wang L, Compston DA, Tofts P, Miller DH. T1 hypointense lesion load in secondary progressive multiple sclerosis: a comparison of pre versus post contrast loads and of manual versus semi automated threshold techniques for lesion segmentation. Mult Scler. 1998 Oct;4(5):408-12. doi: 10.1177/135245859800400502.
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BACKGROUND
Chitnis T, Tardieu M, Amato MP, Banwell B, Bar-Or A, Ghezzi A, Kornberg A, Krupp LB, Pohl D, Rostasy K, Tenembaum S, Waubant E, Wassmer E. International Pediatric MS Study Group Clinical Trials Summit: meeting report. Neurology. 2013 Mar 19;80(12):1161-8. doi: 10.1212/WNL.0b013e318288694e.
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BACKGROUND
Sormani MP, Bonzano L, Roccatagliata L, Cutter GR, Mancardi GL, Bruzzi P. Magnetic resonance imaging as a potential surrogate for relapses in multiple sclerosis: a meta-analytic approach. Ann Neurol. 2009 Mar;65(3):268-75. doi: 10.1002/ana.21606.
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BACKGROUND
Sormani MP, Stubinski B, Cornelisse P, Rocak S, Li D, De Stefano N. Magnetic resonance active lesions as individual-level surrogate for relapses in multiple sclerosis. Mult Scler. 2011 May;17(5):541-9. doi: 10.1177/1352458510391837. Epub 2010 Dec 9.
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BACKGROUND
Sormani MP, Bruzzi P, Beckmann K, Wagner K, Miller DH, Kappos L, Filippi M; European Study Group on Interferon Beta-1b in Secondary Progressive MS. MRI metrics as surrogate endpoints for EDSS progression in SPMS patients treated with IFN beta-1b. Neurology. 2003 May 13;60(9):1462-6. doi: 10.1212/01.wnl.0000063312.15758.b3.
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BACKGROUND
Pascual AM, Martinez-Bisbal MC, Bosca I, Valero C, Coret F, Martinez-Granados B, Marti-Bonmati L, Mir A, Celda B, Casanova B. Axonal loss is progressive and partly dissociated from lesion load in early multiple sclerosis. Neurology. 2007 Jul 3;69(1):63-7. doi: 10.1212/01.wnl.0000265054.08610.12.
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BACKGROUND
Popescu V, Agosta F, Hulst HE, Sluimer IC, Knol DL, Sormani MP, Enzinger C, Ropele S, Alonso J, Sastre-Garriga J, Rovira A, Montalban X, Bodini B, Ciccarelli O, Khaleeli Z, Chard DT, Matthews L, Palace J, Giorgio A, De Stefano N, Eisele P, Gass A, Polman CH, Uitdehaag BM, Messina MJ, Comi G, Filippi M, Barkhof F, Vrenken H; MAGNIMS Study Group. Brain atrophy and lesion load predict long term disability in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1082-91. doi: 10.1136/jnnp-2012-304094. Epub 2013 Mar 23.
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BACKGROUND
Barkhof F, Calabresi PA, Miller DH, Reingold SC. Imaging outcomes for neuroprotection and repair in multiple sclerosis trials. Nat Rev Neurol. 2009 May;5(5):256-66. doi: 10.1038/nrneurol.2009.41.
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Rudick RA, Lee JC, Nakamura K, Fisher E. Gray matter atrophy correlates with MS disability progression measured with MSFC but not EDSS. J Neurol Sci. 2009 Jul 15;282(1-2):106-11. doi: 10.1016/j.jns.2008.11.018. Epub 2008 Dec 19.
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BACKGROUND
Yaldizli O, Penner IK, Frontzek K, Naegelin Y, Amann M, Papadopoulou A, Sprenger T, Kuhle J, Calabrese P, Radu EW, Kappos L, Gass A. The relationship between total and regional corpus callosum atrophy, cognitive impairment and fatigue in multiple sclerosis patients. Mult Scler. 2014 Mar;20(3):356-64. doi: 10.1177/1352458513496880. Epub 2013 Aug 19.
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BACKGROUND
Till C, Ghassemi R, Aubert-Broche B, Kerbrat A, Collins DL, Narayanan S, Arnold DL, Desrocher M, Sled JG, Banwell BL. MRI correlates of cognitive impairment in childhood-onset multiple sclerosis. Neuropsychology. 2011 May;25(3):319-32. doi: 10.1037/a0022051.
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BACKGROUND
Sormani MP, Arnold DL, De Stefano N. Treatment effect on brain atrophy correlates with treatment effect on disability in multiple sclerosis. Ann Neurol. 2014 Jan;75(1):43-9. doi: 10.1002/ana.24018. Epub 2014 Jan 2.
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BACKGROUND
Bjartmar C, Kidd G, Mork S, Rudick R, Trapp BD. Neurological disability correlates with spinal cord axonal loss and reduced N-acetyl aspartate in chronic multiple sclerosis patients. Ann Neurol. 2000 Dec;48(6):893-901.
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BACKGROUND
Pugliatti M, Rosati G, Carton H, Riise T, Drulovic J, Vecsei L, Milanov I. The epidemiology of multiple sclerosis in Europe. Eur J Neurol. 2006 Jul;13(7):700-22. doi: 10.1111/j.1468-1331.2006.01342.x.
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BACKGROUND
Kappos L, Moeri D, Radue EW, Schoetzau A, Schweikert K, Barkhof F, Miller D, Guttmann CR, Weiner HL, Gasperini C, Filippi M. Predictive value of gadolinium-enhanced magnetic resonance imaging for relapse rate and changes in disability or impairment in multiple sclerosis: a meta-analysis. Gadolinium MRI Meta-analysis Group. Lancet. 1999 Mar 20;353(9157):964-9. doi: 10.1016/s0140-6736(98)03053-0.
Reference Type
BACKGROUND
Karussis D, Karageorgiou C, Vaknin-Dembinsky A, Gowda-Kurkalli B, Gomori JM, Kassis I, Bulte JW, Petrou P, Ben-Hur T, Abramsky O, Slavin S. Safety and immunological effects of mesenchymal stem cell transplantation in patients with multiple sclerosis and amyotrophic lateral sclerosis. Arch Neurol. 2010 Oct;67(10):1187-94. doi: 10.1001/archneurol.2010.248.
Reference Type
RESULT
Mancardi G, Saccardi R. Autologous haematopoietic stem-cell transplantation in multiple sclerosis. Lancet Neurol. 2008 Jul;7(7):626-36. doi: 10.1016/S1474-4422(08)70138-8.
Reference Type
RESULT
Nash RA, Hutton GJ, Racke MK, Popat U, Devine SM, Griffith LM, Muraro PA, Openshaw H, Sayre PH, Stuve O, Arnold DL, Spychala ME, McConville KC, Harris KM, Phippard D, Georges GE, Wundes A, Kraft GH, Bowen JD. High-dose immunosuppressive therapy and autologous hematopoietic cell transplantation for relapsing-remitting multiple sclerosis (HALT-MS): a 3-year interim report. JAMA Neurol. 2015 Feb;72(2):159-69. doi: 10.1001/jamaneurol.2014.3780.
Reference Type
RESULT
Rice CM, Mallam EA, Whone AL, Walsh P, Brooks DJ, Kane N, Butler SR, Marks DI, Scolding NJ. Safety and feasibility of autologous bone marrow cellular therapy in relapsing-progressive multiple sclerosis. Clin Pharmacol Ther. 2010 Jun;87(6):679-85. doi: 10.1038/clpt.2010.44. Epub 2010 May 5.
Reference Type
RESULT
Other Identifiers
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PRT/NOVO/2015/002
Identifier Type: -
Identifier Source: org_study_id
NCT02418351
Identifier Type: -
Identifier Source: nct_alias
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A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis
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COMPLETED
PHASE2
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PHASE2
Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis
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AVAILABLE
Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease Progression and Cellular Kinetics Following YTB323 Administration in Participants With Non-active Progressive Multiple Sclerosis (PMS)
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RECRUITING
PHASE1/PHASE2
A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
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RECRUITING
PHASE3
An Observational Biomarker Study in Multiple Sclerosis (MS) Patients
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COMPLETED
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COMPLETED
PHASE1