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Mesenchymal Cells From Autologous Bone Marrow, Administered Intravenously in Patients Diagnosed With Multiple Sclerosis

This study is currently recruiting participants.
Verified September 2017 by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Sponsor:
ClinicalTrials.gov Identifier:
NCT01745783
First Posted: December 10, 2012
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Iniciativa Andaluza en Terapias Avanzadas
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
  Purpose

This is a phase I / II for the evaluation of the safety and feasibility of intravenous infusion of mesenchymal cells from autologous bone marrow in patients with Multiple Sclerosis.

Intravenous administration of autologous mesenchymal cells of bone marrow is feasible and safe and can be effective in treating patients suffering from multiple sclerosis.


Condition Intervention Phase
Multiple Sclerosis Other: Bone marrow mesenchymal stem cells autologous Other: Placebo comparator Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial Phase I / II Multicenter, Randomized, Crossover, Double-blind Evaluation of the Safety and Feasibility of Systemic Therapy With Mesenchymal Cells Derived From Autologous Bone Marrow in Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • Absence of unexpected serious adverse reactions as a measure of safety and reduction in number and volumes of the lesions on magnetic resonance image [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Differences the results obtained in the two groups of patients due to determined parameters. [ Time Frame: 12 months ]

    Secondary variables consist of differences the results obtained in the two groups of patients (treated versus treated at day 0 to day +180) at 12 month follow-up with respect to the following parameters:

    1. Disease activity on magnetic resonance (used one single combined index activity consisting of the presence of new or enlarged T2 or new or recurrence of injury).
    2. Changes in Expanded Disability Status Scale (EDSS).
    3. Changes Multiple Sclerosis Functional Composite (MSFC).
    4. Changes in quality of life scales
    5. Outbreaks: number and proportion of time off outbreaks.
    6. Disease-free patients (no sprouts, no progression and no activity in the RM).


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental

Receive a single IV administration of cellular product (Bone marrow mesenchymal stem cells autologous) on Day 0 and placebo infusion on day + 180.

Dose: 1-2x10^6 cells/Kg

Other: Bone marrow mesenchymal stem cells autologous
Infusion of mesenchymal cells from autologous bone marrow in a dose of 1-2x106 cells / kg
Placebo Comparator: Placebo Comparator
Receive a placebo infusion on day 0 and a single administration cellular product on day +180. Dose: 1-2x10^6 cells/Kg
Other: Placebo comparator
Lactated Ringer's solution, 2.5% glucose and 1% human albumin.

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Patients diagnosed with MS in their inflammatory forms :

  1. Course outbreaks ( relapsing- remitting ) , who have not responded to at least one year of treatment with one or more of the approved therapies (beta - interferon, glatiramer acetate, natalizumab , mitoxantrone, fingolimod ) , confirmed by one or more of the following criteria:

    ( ii ) At least one clinically documented outbreak in the past 12 months. ( iii ) At least two clinically documented outbreaks in the last 24 months ( iv ) At least one lesion with gadolinium on MRI performed in the last 12 months.

    b . Secondary progressive forms that have not responded to at least one year of treatment with one or more of the approved therapies ( interferon beta , glatiramer acetate, natalizumab , mitoxantrone, fingolimod ) . That meet the following criteria:

    ( i ) Increase of 1 point or more if baseline EDSS score is less than or equal to 5.0 , or 0.5 point increase if the baseline score is greater than or equal to 5.5, in the last 12 months.

    ( ii ) at least one clinically documented outbreak or at least one lesion with gadolinium on MRI within the last 12 months.

    c . Primary progressive forms that meet the following three criteria:

    ( i ) Increase of 1 point or more if baseline EDSS score is less than or equal to 5.0 , or 0.5 point increase if the baseline score is greater than or equal to 5.5, in the last 12 months.

    ( ii ) At least 1 lesion with gadolinium on MRI within the last 12 months. ( iii ) oligoclonal bands in cerebrospinal fluid (CSF) .

    2 . Normal laboratory parameters , defined by:

    • Leukocytes ≥ 3000
    • Neutrophils ≥ 1500
    • Platelets ≥ 100,000
    • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≤ 2.5 standard range institution
    • Creatinine ≤ 2.5 mg / dl

      3 . Patients of both sexes aged between 18 and 50.

      4 . Disease duration ≥ 2 years and ≤ 10 years.

      5 . EDSS (Expanded Disability Status Scale) between 3.0 and 6.5 points.

      6. Patients give their informed consent for participation in the clinical trial consent.

      7. Women of childbearing potential must have negative results on a pregnancy test at the time of inclusion in the study and agree to use a medically approved method of contraception while on study

    Exclusion Criteria:

    1. Any active or chronic infection, including Hepatitis B virus (HBV), Hepatitis C virus (HCV) or HIV .
    2. Immunosuppressive therapy in the 3 months prior to randomization (including natalizumab and fingolimod ).
    3. Treatment with interferon beta or glatiramer acetate in the 30 days prior to randomization .
    4. Corticosteroid therapy in the 30 days prior to randomization.
    5. Time since last exceeding 60 days prior to randomization outbreak.
    6. History of malignancy ( basal cell carcinoma of skin and carcinoma in situ are excluded in remission for over a year).
    7. Life expectancy severely limited by other co - morbidities.
    8. Previous history of myelodysplasia or hematological disease , or clinically relevant changes currently in the leukocyte count.
    9. Pregnancy / risk of pregnancy (including refusal to use contraception)
    10. Renal failure (eGFR <60 mL/min/1.37m2)
    11. Inability to undergo MRI scans
    12. Inability to give written informed consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745783


Contacts
Contact: Ana Cardesa 0034 955019040 ana.cardesa@juntadeandalucia.es

Locations
Spain
University Hospital Reina Sofia Recruiting
Córdoba, Spain, 14004
Contact: Eduardo Agüera, MD    957010482;    doctoredu@gmail.com   
Principal Investigator: Eduardo Agüera, MD         
University Regional Hospital Carlos Haya Recruiting
Málaga, Spain, 29010
Contact: Victoria Fernández, MD    951291135    victoriae.fernandez.sspa@juntadeandalucia.es   
Principal Investigator: Victoria Fernández, MD         
University Hospital Virgen Macarena Recruiting
Sevilla, Spain, 41009
Contact: Guillermo Izquierdo, MD    607657605    guillermo.izquierdo@neuroinvest.net   
Principal Investigator: Guillermo Izquierdo, MD         
Sponsors and Collaborators
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Iniciativa Andaluza en Terapias Avanzadas
Investigators
Principal Investigator: Guillermo Izquierdo, MD Section Chief of Neurology, University Hospital Virgen Macarena, Spain
Principal Investigator: Eduardo Agüera, MD Section of Neurology, University Hospital Reina Sofía, Spain
Principal Investigator: Victoria Fernández, MD Section of Neurophysiology, University Regional Hospital Carlos Haya, Spain
Study Chair: Inmaculada Concepción Herrera, MD Technical Director of the Cell Therapy Unit, University Hospital Reina Sofia, Spain
  More Information

Additional Information:
Responsible Party: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01745783     History of Changes
Other Study ID Numbers: CeTMMo/EM/2010
2010-023368-42 ( EudraCT Number )
First Submitted: December 3, 2012
First Posted: December 10, 2012
Last Update Posted: September 21, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases