Overview

This trial is active, not recruiting.

Conditions relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis
Treatments xcel-mc-alpha, placebo
Phase phase 1/phase 2
Sponsor Banc de Sang i Teixits
Collaborator Vall d'Hebron Research Institute (VHIR)
Start date May 2015
End date December 2017
Trial size 8 participants
Trial identifier NCT02495766, XCEL-MS-02

Summary

This study evaluates the effect of cryopreserved autologous adult bone-marrow mesenchymal stromal cells (BM-MSC) in patients with active multiple sclerosis, compared to placebo.

Patients will be allocated to one of the 2 treatment arms (BM-MSC or placebo)and at month 6, the treatment will be crossed to receive the other product. The objective is to assess the safety of a single infusion BM-MSC, and to explore its efficacy in these patients.

Patients will be evaluated at month 12 and will be followed-up for a total of 3 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Single infusion of cryopreserved bone-marrow adult mesenchymal stromal cells followed by placebo infusion at month 6.
xcel-mc-alpha Bone-marrow mesenchymal stromal cells
Single infusion
placebo
Single infusion
(Experimental)
Single infusion of placebo followed by cryopreserved bone-marrow adult mesenchymal stromal cells infusion at month 6.
xcel-mc-alpha Bone-marrow mesenchymal stromal cells
Single infusion
placebo
Single infusion

Primary Outcomes

Measure
Adverse events
time frame: 12 months

Secondary Outcomes

Measure
Cumulative number of MRI Gd-enhancing lesions
time frame: 12 months
Multiple Sclerosis Outbreaks
time frame: 12 months
Expanded Disability Status Scale (EDDS) score
time frame: 12 months
Cumulative number of lesions visualized on T2 sequence
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - Patients between 18 and 60 years of age - Patients with MS - Relapsing-remitting or secondary progressive MS - Patients to whom are not indicated or are not in a position to initiate treatment with disease-modifying drugs - Expanded Disability Status Scale (EDDS) score <6.5 - Nine T2 lesions at least - Active multiple sclerosis as defined either by 1 outbreak in the last year or at least one Gadolinium-enhancing lesion in the last 6 months - Signed informed consent form Exclusion Criteria: - Interferon beta or glatiramer acetate 3 months prior the screening - Natalizumab or fingolimod in the 6 months prior the screening - Mitoxantrone, cyclophosphamide or other immunosuppressive therapy at any time - Has received an experimental treatment within 3 months prior the screening - MS outbreak within the 4 weeks prior the randomization - Serum creatinine> 2.0 mg/dl - Infectious disease active or uncontrolled - Fertile patients who are not using a suitable method of contraception - Pregnant or lactating woman - Immunodeficiency - Positive serology to HIV, Hepatitis B, Hepatitis C or syphilis

Additional Information

Official title Treatment of Autologous Mesenchymal Stem Cells Derived From Bone Marrow as a Potential Therapeutic Strategy for the Treatment of Multiple Sclerosis
Principal investigator Xavier Montalban, MD, PhD
Description To date, there is no effective therapy to cure multiple sclerosis (MS). Immunomodulatory therapies are useful in reducing the frequency of inflammatory processes (relapses) but don't delay significantly the progression of the disease, prevent long term disability or induce the repair of damaged tissue. This proposal contemplates the use of adult autologous bone marrow mesenchymal stromal cells (BM-MSC) as an alternative therapeutic strategy to treat patients with active MS. This is a randomized, double blind, crossover clinical trial in which 8 patients with active forms of MS and moderate disability will enter the trial with the primary objective of assessing the safety and tolerability of a single intravenous infusion of BM-MSC. Secondary objectives are to assess the efficacy by gadolinium enhancing lesions though magnetic resonance imaging, neurophysiological effects and immunological effects. Once randomized, patients will undergo BM extraction and once confirmed the availability of the needed dose, they will be randomized to one of the 2 treatment arms (BM-MSC named XCEL-MC-ALPHA, or placebo). XCEL-MC-ALPHA will be cryopreserved for all patients regardless the allocated arm. At month 6, the treatment will be crossed. Patients will be evaluated at month 12 and will be followed-up for a total of 3 years.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Banc de Sang i Teixits.