NCT01745783

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P50-P75 for phase_1 multiple-sclerosis

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_1 multiple-sclerosis

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

7.5 years

First QC Date

December 3, 2012

Last Update Submit

April 5, 2022

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Absence of unexpected serious adverse reactions as a measure of safety and reduction in number and volumes of the lesions on magnetic resonance image

    12 months

Secondary Outcomes (1)

  • Differences the results obtained in the two groups of patients due to determined parameters.

    12 months

Study Arms (2)

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

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

Interventions

Bone marrow mesenchymal stem cells autologousOTHER

Infusion of mesenchymal cells from autologous bone marrow in a dose of 1-2x106 cells / kg

Experimental
Placebo comparatorOTHER

Lactated Ringer's solution, 2.5% glucose and 1% human albumin.

Placebo Comparator

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Patients diagnosed with MS in their inflammatory forms :
  • 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) .
  • 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
  • +4 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Reina Sofia

Córdoba, 14004, Spain

Location

University Regional Hospital Carlos Haya

Málaga, 29010, Spain

Location

University Hospital Virgen Macarena

Seville, 41009, Spain

Location

Related Publications (1)

  • Uccelli A, Laroni A, Brundin L, Clanet M, Fernandez O, Nabavi SM, Muraro PA, Oliveri RS, Radue EW, Sellner J, Soelberg Sorensen P, Sormani MP, Wuerfel JT, Battaglia MA, Freedman MS; MESEMS study group. MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis. Trials. 2019 May 9;20(1):263. doi: 10.1186/s13063-019-3346-z.

    PMID: 31072380DERIVED

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Inmaculada Concepción Herrera, MD

    Technical Director of the Cell Therapy Unit, University Hospital Reina Sofia, Spain

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 10, 2012

Study Start

January 1, 2013

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

April 6, 2022

Record last verified: 2022-04

Locations

ES(3)