NCT01056471

Brief Summary

The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with mesenchymal stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who do not respond to treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

January 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 7, 2015

Status Verified

February 1, 2015

Enrollment Period

2.4 years

First QC Date

January 25, 2010

Last Update Submit

August 4, 2015

Conditions

Autoimmune DiseasesImmune System DiseasesDemyelinating DiseasesNervous System DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous System

Keywords

Multiple SclerosisMesenchymal Stem CellsAutologous

Outcome Measures

Primary Outcomes (1)

  • To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells

    12 months.

Secondary Outcomes (1)

  • To evaluate effects on MS disease activity measured by: clinical variables, imaging variables, immunological and neurophysiologic analysis, neuropsychological and quality of life scales.

    12 months

Study Arms (3)

Low dose autologous mesenchymal cells

EXPERIMENTAL

The dose of infused cells is 10e6 cells/Kg

Other: Autologous mesenchymal stem cells from adipose tissue.

High dose

EXPERIMENTAL

The dose of infused cells is 4\*10e6 cells/Kg

Other: Autologous mesenchymal stem cells from adipose tissue.

Placebo Control

NO INTERVENTION

Interventions

Autologous mesenchymal stem cells from adipose tissue.OTHER

Intravenous infusion of autologous mesenchymal stem cells.Dose:4\*10e6 cells/Kg.

High dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with Multiple Sclerosis (Poser and McDonald criteria).
  • Secondary progressive MS patients with EDSS ≥ 5.5 and ≤ 9.
  • Patients with treatment failure defined by: no response to immunomodulators / immunosuppressants, and showing activity in the form of 1 relapse in the last year or 0.5 points in EDSS progression.
  • Patients who give written consent to participate in the study. -

You may not qualify if:

  • History of current pathology or current laboratory results indicative of any severe disease.
  • Pacemaker or metallic implants that prevent MR imaging.
  • Inability to complete questionnaires.
  • Refusal to give informed consent.
  • Predicted impossibility for a biopsy of at least 30 grams of fat tissue.
  • Positive screening test for HIV, Hepatitis B or Hepatitis C.
  • History of malignancy.
  • Having been in treatment with any investigational drug or have undergone any experimental procedure in the 3 months prior to baseline.
  • Body mass index\> 40 kg/m2.
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Regional Universitario de Málaga

Málaga, Málaga, 29010, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Sevilla, 41004, Spain

Location

Related Links

MeSH Terms

Conditions

Autoimmune DiseasesImmune System DiseasesDemyelinating DiseasesNervous System DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemMultiple Sclerosis

Condition Hierarchy (Ancestors)

LeukoencephalopathiesBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Oscar Fernandez Fernandez, MD, PhD

    Hospital Regional Universitario Carlos Haya, Málaga, Spain.

    STUDY DIRECTOR

  • Guillermo Izquierdo Ayuso, MD, PhD

    Hospital Universitario Virgen Macarena, Sevilla, Spain

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 26, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2015

Last Updated

August 7, 2015

Record last verified: 2015-02

Locations

ES(2)