<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01679041</url>
  </required_header>
  <id_info>
    <org_study_id>20112015</org_study_id>
    <nct_id>NCT01679041</nct_id>
  </id_info>
  <brief_title>High Dose Chemo With Stem Cell Transplant as Treatment for Multiple Sclerosis That Failed Prior Treatment</brief_title>
  <official_title>A Phase II Study of High Dose Chemotherapy With Autologous Hematopoietic Progenitor Cell Transplant for Multiple Sclerosis That Failed at Least Two Lines of Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seah Lim M.D.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Oncology Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the toxicity and the effectiveness of high dose&#xD;
      chemotherapy with HPC transplant Multiple Sclerosis that has failed at least two lines of&#xD;
      therapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple sclerosis is an inflammatory autoimmune disease characterized by loss of myelin and&#xD;
      axonal damage, having typical contrast-enhanced MRI foci as an imaging counterpart. MS shows&#xD;
      three main patterns of clinical course: relapsing/remitting, primary progressive and&#xD;
      secondary progressive.Concerning disease pattern, secondary progressive is the standard&#xD;
      indication, to avoid overtreatment in relapsing/remitting patients or ineffectual treatment&#xD;
      in primary relapsing patients.&#xD;
&#xD;
      Currently, MS is the most common autoimmune disease that have been treated with autologous&#xD;
      HPC transplants (Fagius et al, 2009; Burt et al, 2009; Saccardi et al, 2006). More than 350&#xD;
      consecutive cases have been reported by the EBMT over the last decade. Most patients who&#xD;
      underwent autologous HPC transplant for MS in the early studies had secondary progressive MS,&#xD;
      and relatively fewer had relapsing remitting disease, with a Kurtzke Expanded Disability&#xD;
      Status Scale (EDSS) of 3.0-9.5 at the time of transplant. Significant objective and&#xD;
      subjective improvements have been reported in up to 70% of these patients.&#xD;
&#xD;
      The following conditioning regimens will be used, with Alemtuzumab, Fludarabine, and&#xD;
      Cyclophosphamide will be used for all patients. Prophylaxis of Acyclovir, Levaquin, and&#xD;
      Fluconazole will be given to prevent infections. The autologous HPC will be infused within&#xD;
      48-72 hours of completing the chemotherapy. The patients will receive additional supportive&#xD;
      care medications and treatments as necessary. Neutrophil engraftment will be defined as the&#xD;
      day on which the ANC rises to &gt; 500 cells/ml for two consecutive days. Platelet engraftment&#xD;
      will be defined as the first day on which the platelet count rises to &gt; 20,000/ml over a&#xD;
      7-day interval without transfusion support.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient accruals; PI leaving site&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the toxicity of autologous HPC transplant in patients with multiple sclerosis that have failed at least two lines of disease modifier therapy</measure>
    <time_frame>At 5 years post transplant</time_frame>
    <description>All follow-up appointments will be carried out at Texas Oncology-Amarillo Cancer Center. Patients will be monitored for clinical toxicities and using laboratory blood tests for renal functions, hepatic functions, and bone marrow functions at At discharge post-transplant, then again at 6 weeks, 3 months, 6 months, 9 months, 12 months and after that 6 monthly until death..</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the effectiveness of high dose chemotherapy with HPC transplant for multiple sclerosis sclerosis that has failed at least two lines of therapy</measure>
    <time_frame>Assessed at baseline, tat 3 months, 6 months, 9 months, 12 months, and then after every 12 months until death</time_frame>
    <description>hen rechecked Neurologic evaluations will be carried out in the offices of the two neurology co-Investigators and the information provided to the transplant physicians for record. Patient will also undergo a repeat MRI scan at 3 months, 6 months, 9 months, 12 months, and then after every 12 months until death, after the transplant to evaluate changes in the number of MS plaques. Subsequent MRI scan will be determined by the patient's neurologist as is needed clinically.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Single Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conditioning regimens with Alemtuzumab, Fludarabine, and Cyclophosphamide will be used for all patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alemtuzumab</intervention_name>
    <description>Alemtuzumab 10 mg given IV on day 1 of the 5 day conditional regimen</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fludarabine</intervention_name>
    <description>Fludarabine 25mg/m2 daily given IV on days 1-5 of the 5 day conditioning regimen</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Cyclophosphamide is given 3 gm/m2 for mobilization, and then repeated during 5 day conditioning regimen w/ doses of 50mg/kg/day on days 1-4</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age between 18-60, inclusive&#xD;
&#xD;
        Patients carry a diagnosis of multiple sclerosis, according to the McDonald's criteria for&#xD;
        diagnosis (Polman et al, 2011).&#xD;
&#xD;
        Must have a neurologist providing the primary care for the MS and be willing to be&#xD;
        evaluated for the multiple sclerosis by the two neurologists who are the co-investigators&#xD;
        in the protocol.&#xD;
&#xD;
        Must be documented to be HIV negative.&#xD;
&#xD;
        An EDSS of 3.5 - 5.5&#xD;
&#xD;
        Patients must be able to give written consent.&#xD;
&#xD;
        Inflammatory disease despite primary disease modifying therapy with at least 6 months of&#xD;
        interferon and another disease modifying therapy, including fingolimod,glativamir,&#xD;
        natalizumab, and mitoxantrone. Failure is defined as two or more clinical relapses with&#xD;
        documented neurologic changes (excluding sensory changes) within the year prior to the&#xD;
        study. (NOTE: Relapses must have required treatment with corticosteroids). Failure may also&#xD;
        be defined as one relapse (excluding sensory changes) treated with methylprednisone and, on&#xD;
        a separate occasion within the previous 12 months, evidence of active inflammation (i.e.&#xD;
        gadolinium enhancement on MRI scan of the CNS).&#xD;
&#xD;
        No previous history of allergic reaction to cyclophosphamide, G-CSF or mesna&#xD;
&#xD;
        Patients must not be pregnant&#xD;
&#xD;
        Failure to accept or comprehend irreversible sterility as a potential side effect of&#xD;
        therapy.&#xD;
&#xD;
        Life expectancy of more than 6 months&#xD;
&#xD;
        No evidence of myelodysplastic syndrome on peripheral blood smear&#xD;
&#xD;
        Not allergic to cyclophosphamide, mesna, fludarabine or alemtuzumab&#xD;
&#xD;
        Baseline serum creatinine must be &lt;1.5 mg/dL, left ventricular ejection fraction &gt;55%,&#xD;
        adequate pulmonary functions (oxygen saturation at room air of &gt;90%), and AST and ALT not &gt;&#xD;
        2x upper limits of normal, and no history of previous or active malignancy, except for&#xD;
        localized cutaneous basal or squamous cell carcinoma in situ of the cervix.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Diagnosis of primary progressive MS.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seah Lim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amarillo Diagnostic Clinic</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Ruby Saulog</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Burt RK, Loh Y, Cohen B, Stefoski D, Balabanov R, Katsamakis G, Oyama Y, Russell EJ, Stern J, Muraro P, Rose J, Testori A, Bucha J, Jovanovic B, Milanetti F, Storek J, Voltarelli JC, Burns WH. Autologous non-myeloablative haemopoietic stem cell transplantation in relapsing-remitting multiple sclerosis: a phase I/II study. Lancet Neurol. 2009 Mar;8(3):244-53. doi: 10.1016/S1474-4422(09)70017-1. Epub 2009 Jan 29. Erratum In: Lancet Neurol. 2009 Apr;8(4):309. Stefosky, Dusan [corrected to Stefoski, Dusan].</citation>
    <PMID>19186105</PMID>
  </reference>
  <reference>
    <citation>Burt RK, Marmont A, Oyama Y, Slavin S, Arnold R, Hiepe F, Fassas A, Snowden J, Schuening F, Myint H, Patel DD, Collier D, Heslop H, Krance R, Statkute L, Verda L, Traynor A, Kozak T, Hintzen RQ, Rose JW, Voltarelli J, Loh Y, Territo M, Cohen BA, Craig RM, Varga J, Barr WG. Randomized controlled trials of autologous hematopoietic stem cell transplantation for autoimmune diseases: the evolution from myeloablative to lymphoablative transplant regimens. Arthritis Rheum. 2006 Dec;54(12):3750-60. doi: 10.1002/art.22256. No abstract available.</citation>
    <PMID>17133541</PMID>
  </reference>
  <reference>
    <citation>Fagius J, Lundgren J, Oberg G. Early highly aggressive MS successfully treated by hematopoietic stem cell transplantation. Mult Scler. 2009 Feb;15(2):229-37. doi: 10.1177/1352458508096875. Epub 2008 Sep 19.</citation>
    <PMID>18805841</PMID>
  </reference>
  <reference>
    <citation>Kimiskidis V, Sakellari I, Tsimourtou V, Kapina V, Papagiannopoulos S, Kazis D, Vlaikidis N, Anagnostopoulos A, Fassas A. Autologous stem-cell transplantation in malignant multiple sclerosis: a case with a favorable long-term outcome. Mult Scler. 2008 Mar;14(2):278-83. doi: 10.1177/1352458507082604. Epub 2007 Oct 17.</citation>
    <PMID>17942513</PMID>
  </reference>
  <reference>
    <citation>Lim SH, Kell J, al-Sabah A, Bashi W, Bailey-Wood R. Peripheral blood stem-cell transplantation for refractory autoimmune thrombocytopenic purpura. Lancet. 1997 Feb 15;349(9050):475. doi: 10.1016/S0140-6736(05)61187-7. No abstract available.</citation>
    <PMID>9040585</PMID>
  </reference>
  <reference>
    <citation>Mancardi GL, Murialdo A, Rossi P, Gualandi F, Martino G, Marmont A, Ciceri F, Schenone A, Parodi RC, Capello E, Comi G, Uccelli A. Autologous stem cell transplantation as rescue therapy in malignant forms of multiple sclerosis. Mult Scler. 2005 Jun;11(3):367-71. doi: 10.1191/1352458505ms1181cr.</citation>
    <PMID>15957523</PMID>
  </reference>
  <reference>
    <citation>Pasquini MC, Griffith LM, Arnold DL, Atkins HL, Bowen JD, Chen JT, Freedman MS, Kraft GH, Mancardi GL, Martin R, Muraro PA, Nash RA, Racke MK, Storek J, Saccardi R. Hematopoietic stem cell transplantation for multiple sclerosis: collaboration of the CIBMTR and EBMT to facilitate international clinical studies. Biol Blood Marrow Transplant. 2010 Aug;16(8):1076-83. doi: 10.1016/j.bbmt.2010.03.012. Epub 2010 Mar 18.</citation>
    <PMID>20304084</PMID>
  </reference>
  <reference>
    <citation>Passweg J, Tyndall A. Autologous stem cell transplantation in autoimmune diseases. Semin Hematol. 2007 Oct;44(4):278-85. doi: 10.1053/j.seminhematol.2007.08.001.</citation>
    <PMID>17961728</PMID>
  </reference>
  <reference>
    <citation>Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.</citation>
    <PMID>21387374</PMID>
  </reference>
  <reference>
    <citation>Saccardi R, Di Gioia M, Bosi A. Haematopoietic stem cell transplantation for autoimmune disorders. Curr Opin Hematol. 2008 Nov;15(6):594-600. doi: 10.1097/MOH.0b013e3283136700.</citation>
    <PMID>18832930</PMID>
  </reference>
  <reference>
    <citation>Saccardi R, Kozak T, Bocelli-Tyndall C, Fassas A, Kazis A, Havrdova E, Carreras E, Saiz A, Lowenberg B, te Boekhorst PA, Gualandio F, Openshaw H, Longo G, Pagliai F, Massacesi L, Deconink E, Ouyang J, Nagore FJ, Besalduch J, Lisukov IA, Bonini A, Merelli E, Slavino S, Gratwohl A, Passweg J, Tyndall A, Steck AJ, Andolina M, Capobianco M, Martin JL, Lugaresi A, Meucci G, Saez RA, Clark RE, Fernandez MN, Fouillard L, Herstenstein B, Koza V, Cocco E, Baurmann H, Mancardi GL; Autoimmune Diseases Working Party of EBMT. Autologous stem cell transplantation for progressive multiple sclerosis: update of the European Group for Blood and Marrow Transplantation autoimmune diseases working party database. Mult Scler. 2006 Dec;12(6):814-23. doi: 10.1177/1352458506071301.</citation>
    <PMID>17263012</PMID>
  </reference>
  <reference>
    <citation>Tyndall A, Gratwohl A. Adult stem cell transplantation in autoimmune disease. Curr Opin Hematol. 2009 Jul;16(4):285-91. doi: 10.1097/MOH.0b013e32832aacb3.</citation>
    <PMID>19465851</PMID>
  </reference>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>November 21, 2013</last_update_submitted>
  <last_update_submitted_qc>November 21, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 25, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Texas Oncology Cancer Center</investigator_affiliation>
    <investigator_full_name>Seah Lim M.D.</investigator_full_name>
    <investigator_title>Sponsor-Principal Investigator (MD)</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Fludarabine</mesh_term>
    <mesh_term>Alemtuzumab</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01679041
org study id: 20112015
nct id: NCT01679041
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the toxicity and the effectiveness of high dose
      chemotherapy with HPC transplant Multiple Sclerosis that has failed at least two lines of
      therapy
Multiple sclerosis is an inflammatory autoimmune disease characterized by loss of myelin and
      axonal damage, having typical contrast-enhanced MRI foci as an imaging counterpart. MS shows
      three main patterns of clinical course: relapsing/remitting, primary progressive and
      secondary progressive.Concerning disease pattern, secondary progressive is the standard
      indication, to avoid overtreatment in relapsing/remitting patients or ineffectual treatment
      in primary relapsing patients.

      Currently, MS is the most common autoimmune disease that have been treated with autologous
      HPC transplants (Fagius et al, 2009; Burt et al, 2009; Saccardi et al, 2006). More than 350
      consecutive cases have been reported by the EBMT over the last decade. Most patients who
      underwent autologous HPC transplant for MS in the early studies had secondary progressive MS,
      and relatively fewer had relapsing remitting disease, with a Kurtzke Expanded Disability
      Status Scale (EDSS) of 3.0-9.5 at the time of transplant. Significant objective and
      subjective improvements have been reported in up to 70% of these patients.

      The following conditioning regimens will be used, with Alemtuzumab, Fludarabine, and
      Cyclophosphamide will be used for all patients. Prophylaxis of Acyclovir, Levaquin, and
      Fluconazole will be given to prevent infections. The autologous HPC will be infused within
      48-72 hours of completing the chemotherapy. The patients will receive additional supportive
      care medications and treatments as necessary. Neutrophil engraftment will be defined as the
      day on which the ANC rises to > 500 cells/ml for two consecutive days. Platelet engraftment
      will be defined as the first day on which the platelet count rises to > 20,000/ml over a
      7-day interval without transfusion support.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To evaluate the toxicity of autologous HPC transplant in patients with multiple sclerosis that have failed at least two lines of disease modifier therapy
time frame: At 5 years post transplant
description: All follow-up appointments will be carried out at Texas Oncology-Amarillo Cancer Center. Patients will be monitored for clinical toxicities and using laboratory blood tests for renal functions, hepatic functions, and bone marrow functions at At discharge post-transplant, then again at 6 weeks, 3 months, 6 months, 9 months, 12 months and after that 6 monthly until death..
measure: To evaluate the effectiveness of high dose chemotherapy with HPC transplant for multiple sclerosis sclerosis that has failed at least two lines of therapy
time frame: Assessed at baseline, tat 3 months, 6 months, 9 months, 12 months, and then after every 12 months until death
description: hen rechecked Neurologic evaluations will be carried out in the offices of the two neurology co-Investigators and the information provided to the transplant physicians for record. Patient will also undergo a repeat MRI scan at 3 months, 6 months, 9 months, 12 months, and then after every 12 months until death, after the transplant to evaluate changes in the number of MS plaques. Subsequent MRI scan will be determined by the patient's neurologist as is needed clinically.
arm group label: Single Arm
arm group type: Experimental
description: Conditioning regimens with Alemtuzumab, Fludarabine, and Cyclophosphamide will be used for all patients.
intervention type: Drug
intervention name: Alemtuzumab
description: Alemtuzumab 10 mg given IV on day 1 of the 5 day conditional regimen
arm group label: Single Arm
intervention type: Drug
intervention name: Fludarabine
description: Fludarabine 25mg/m2 daily given IV on days 1-5 of the 5 day conditioning regimen
arm group label: Single Arm
intervention type: Drug
intervention name: Cyclophosphamide
description: Cyclophosphamide is given 3 gm/m2 for mobilization, and then repeated during 5 day conditioning regimen w/ doses of 50mg/kg/day on days 1-4
arm group label: Single Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Seah Lim, MD
role: Principal Investigator
affiliation: Texas Oncology
facility: 
facility: 
facility: 
country: United States
citation: Burt RK, Loh Y, Cohen B, Stefoski D, Balabanov R, Katsamakis G, Oyama Y, Russell EJ, Stern J, Muraro P, Rose J, Testori A, Bucha J, Jovanovic B, Milanetti F, Storek J, Voltarelli JC, Burns WH. Autologous non-myeloablative haemopoietic stem cell transplantation in relapsing-remitting multiple sclerosis: a phase I/II study. Lancet Neurol. 2009 Mar;8(3):244-53. doi: 10.1016/S1474-4422(09)70017-1. Epub 2009 Jan 29. Erratum In: Lancet Neurol. 2009 Apr;8(4):309. Stefosky, Dusan [corrected to Stefoski, Dusan].
PMID: 19186105
citation: Burt RK, Marmont A, Oyama Y, Slavin S, Arnold R, Hiepe F, Fassas A, Snowden J, Schuening F, Myint H, Patel DD, Collier D, Heslop H, Krance R, Statkute L, Verda L, Traynor A, Kozak T, Hintzen RQ, Rose JW, Voltarelli J, Loh Y, Territo M, Cohen BA, Craig RM, Varga J, Barr WG. Randomized controlled trials of autologous hematopoietic stem cell transplantation for autoimmune diseases: the evolution from myeloablative to lymphoablative transplant regimens. Arthritis Rheum. 2006 Dec;54(12):3750-60. doi: 10.1002/art.22256. No abstract available.
PMID: 17133541
citation: Fagius J, Lundgren J, Oberg G. Early highly aggressive MS successfully treated by hematopoietic stem cell transplantation. Mult Scler. 2009 Feb;15(2):229-37. doi: 10.1177/1352458508096875. Epub 2008 Sep 19.
PMID: 18805841
citation: Kimiskidis V, Sakellari I, Tsimourtou V, Kapina V, Papagiannopoulos S, Kazis D, Vlaikidis N, Anagnostopoulos A, Fassas A. Autologous stem-cell transplantation in malignant multiple sclerosis: a case with a favorable long-term outcome. Mult Scler. 2008 Mar;14(2):278-83. doi: 10.1177/1352458507082604. Epub 2007 Oct 17.
PMID: 17942513
citation: Lim SH, Kell J, al-Sabah A, Bashi W, Bailey-Wood R. Peripheral blood stem-cell transplantation for refractory autoimmune thrombocytopenic purpura. Lancet. 1997 Feb 15;349(9050):475. doi: 10.1016/S0140-6736(05)61187-7. No abstract available.
PMID: 9040585
citation: Mancardi GL, Murialdo A, Rossi P, Gualandi F, Martino G, Marmont A, Ciceri F, Schenone A, Parodi RC, Capello E, Comi G, Uccelli A. Autologous stem cell transplantation as rescue therapy in malignant forms of multiple sclerosis. Mult Scler. 2005 Jun;11(3):367-71. doi: 10.1191/1352458505ms1181cr.
PMID: 15957523
citation: Pasquini MC, Griffith LM, Arnold DL, Atkins HL, Bowen JD, Chen JT, Freedman MS, Kraft GH, Mancardi GL, Martin R, Muraro PA, Nash RA, Racke MK, Storek J, Saccardi R. Hematopoietic stem cell transplantation for multiple sclerosis: collaboration of the CIBMTR and EBMT to facilitate international clinical studies. Biol Blood Marrow Transplant. 2010 Aug;16(8):1076-83. doi: 10.1016/j.bbmt.2010.03.012. Epub 2010 Mar 18.
PMID: 20304084
citation: Passweg J, Tyndall A. Autologous stem cell transplantation in autoimmune diseases. Semin Hematol. 2007 Oct;44(4):278-85. doi: 10.1053/j.seminhematol.2007.08.001.
PMID: 17961728
citation: Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.
PMID: 21387374
citation: Saccardi R, Di Gioia M, Bosi A. Haematopoietic stem cell transplantation for autoimmune disorders. Curr Opin Hematol. 2008 Nov;15(6):594-600. doi: 10.1097/MOH.0b013e3283136700.
PMID: 18832930
citation: Saccardi R, Kozak T, Bocelli-Tyndall C, Fassas A, Kazis A, Havrdova E, Carreras E, Saiz A, Lowenberg B, te Boekhorst PA, Gualandio F, Openshaw H, Longo G, Pagliai F, Massacesi L, Deconink E, Ouyang J, Nagore FJ, Besalduch J, Lisukov IA, Bonini A, Merelli E, Slavino S, Gratwohl A, Passweg J, Tyndall A, Steck AJ, Andolina M, Capobianco M, Martin JL, Lugaresi A, Meucci G, Saez RA, Clark RE, Fernandez MN, Fouillard L, Herstenstein B, Koza V, Cocco E, Baurmann H, Mancardi GL; Autoimmune Diseases Working Party of EBMT. Autologous stem cell transplantation for progressive multiple sclerosis: update of the European Group for Blood and Marrow Transplantation autoimmune diseases working party database. Mult Scler. 2006 Dec;12(6):814-23. doi: 10.1177/1352458506071301.
PMID: 17263012
citation: Tyndall A, Gratwohl A. Adult stem cell transplantation in autoimmune disease. Curr Opin Hematol. 2009 Jul;16(4):285-91. doi: 10.1097/MOH.0b013e32832aacb3.
PMID: 19465851
responsible party type: Sponsor-Investigator
investigator affiliation: Texas Oncology Cancer Center
investigator full name: Seah Lim M.D.
investigator title: Sponsor-Principal Investigator (MD)
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Cyclophosphamide
mesh term: Fludarabine
mesh term: Alemtuzumab