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OpenTrials
Completed

NCT Number: NCT01056471

Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Regional Universitario de Málaga, Málaga, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 with no MS relapse and no steroid treatment within the month prior to inclusion.
  • Patients who give written consent to participate in the study. -

Exclusion criteria

  • 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.
  • Patients who have been treated with prohibited concomitant medication during the month prior to inclusion in the study.
  • Pregnancy or lactation

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Treatment and study plan

Autologous mesenchymal stem cells from adipose tissue.

Other

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

Primary outcomes

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

    Time frame: 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.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Other

Collaborators

  • Carlos III Health Institute

Registry information

Official study title

Multicenter Clinical Trial Phase I / II Randomized, Placebo-controlled Study to Evaluate Safety and Feasibility of Therapy With Two Different Doses of Autologous Mesenchymal Stem Cells in Patients With Secondary Progressive Multiple Sclerosis Who do Not Respond to Treatment

Important dates

Study start
2010
Primary completion
2012
Study completion
2015
First posted
Jan 26, 2010
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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