NCT01228266

Brief Summary

The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate the safety and tolerability of autologous mesenchymal stem cell transplantation in patients with active multiple sclerosis

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_2 multiple-sclerosis

Timeline
Completed

Started Dec 2010

Typical duration for phase_2 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
terminated

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

October 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 13, 2014

Status Verified

February 1, 2014

Enrollment Period

2.5 years

First QC Date

October 25, 2010

Last Update Submit

February 12, 2014

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety as number of severe events along 1 year, and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI at 6 months and at the end of the study

    The coprimary endpoints were safety and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI

    12 months

Secondary Outcomes (1)

  • To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales

    12 months

Study Arms (1)

autologous mesenchymal stem cell

EXPERIMENTAL

A single infusion of up to 2 million cells per Kg of autologous mesenchymal stem cells vs suspension media. The treatment will be reversed at 6 months

Biological: autologous mesenchymal stem cells

Interventions

autologous mesenchymal stem cellsBIOLOGICAL

A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS

autologous mesenchymal stem cell

Eligibility Criteria

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

You may qualify if:

  • Inflammatory forms of MS
  • Relapsing-remitting MS (RRMS) patients
  • Secondary progressive MS (SPMS) patients with continued relapses
  • Primary progressive MS (PPMS) patients with enhancing MRI lesions and positive CSF (oligoclonal banding)
  • Age 18-50 years
  • Disease duration \>= 2 and \>= 10 years
  • EDSS 3.0 - 6.5
  • Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by:
  • Increase of \>= 1 EDSS point (if baseline EDSS \<= 5.0) or 0.5 EDSS points (if baseline EDSS \>= 5.5), or quantifiable, objective evidence of equivalent progression
  • \>= 1 moderate-severe relapses in past 18 months
  • \>= 1 Gadolinium enhancing lesions (double or triple dose Gadolinium)
  • \>= 1 new T2 lesion
  • For PPMS only, \>= 1 Gadolinium enhancing lesions
  • Has given informed consent to participate in the study.

You may not qualify if:

  • SPMS without ongoing relapses
  • PPMS without positive CSF or Gadolinium enhancing lesions
  • \<= 3 months since treatment with any immunosuppressive therapy
  • \<=1 month since last treatment with interferon-B or glatiramer acetate
  • Corticosteroid treatment \<= 30 days
  • Relapse \<= 60 days
  • History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C
  • Any metallic or electronic device that precludes from undergoing MRI
  • Pregnancy or lactation
  • Current treatment with an investigational therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurology Service, Hospital Clinic de barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

  • Llufriu S, Sepulveda M, Blanco Y, Marin P, Moreno B, Berenguer J, Gabilondo I, Martinez-Heras E, Sola-Valls N, Arnaiz JA, Andreu EJ, Fernandez B, Bullich S, Sanchez-Dalmau B, Graus F, Villoslada P, Saiz A. Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis. PLoS One. 2014 Dec 1;9(12):e113936. doi: 10.1371/journal.pone.0113936. eCollection 2014.

    PMID: 25436769DERIVED

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

  • Albert Saiz, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 25, 2010

First Posted

October 26, 2010

Study Start

December 1, 2010

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

February 13, 2014

Record last verified: 2014-02

Locations

ES(1)