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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Fundación Pública Andaluza Progreso y Salud
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT01745783
First received: December 3, 2012
Last updated: December 20, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Differences the results obtained in the two groups of patients due to determined parameters. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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: July 2015
Estimated Primary Completion Date: July 2015 (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: 1-2x106 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.
Other: Placebo comparator
Lactated Ringer's solution, 2.5% glucose and 1% human albumin.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745783

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

Locations
Spain
University Hospital Reina Sofia Recruiting
Córdoba, Spain, 14004
Contact: Fernando Sánchez, MD    957010482;    fernansanzlo@hotmail.com   
Principal Investigator: Fernando Sánchez, MD         
University Regional Hospital Carlos Haya Recruiting
Málaga, Spain, 29010
Contact: Óscar Fernández, MD    951291135    oscar.fernandez.sspa@juntadeandalucia.es   
Principal Investigator: Óscar 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
Fundación Pública Andaluza Progreso y Salud
Investigators
Principal Investigator: Guillermo Izquierdo, MD Section Chief of Neurology, University Hospital Virgen Macarena, Spain
Principal Investigator: Fernando Sánchez, MD Section Chief of Neurology, University Hospital Reina Sofía, Spain
Principal Investigator: Óscar Fernández, MD Section Chief of Neurology, 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:
No publications provided

Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01745783     History of Changes
Other Study ID Numbers: CeTMMo/EM/2010, 2010-023368-42
Study First Received: December 3, 2012
Last Updated: December 20, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

ClinicalTrials.gov processed this record on July 28, 2014