NCT02495766

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

May 11, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

June 3, 2015

Last Update Submit

January 15, 2020

Conditions

Relapsing-Remitting Multiple SclerosisSecondary Progressive Multiple Sclerosis

Keywords

Multiple sclerosisBone marrow mesenchymal stromal cellsStem cellsNervous System DiseasesDemyelinating DiseasesAutoimmune Diseases

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Safety profile

    12 months

Secondary Outcomes (4)

  • Cumulative number of MRI Gd-enhancing lesions

    12 months

  • Multiple Sclerosis Outbreaks

    12 months

  • Expanded Disability Status Scale (EDDS) score

    12 months

  • Cumulative number of lesions visualized on T2 sequence

    12 months

Study Arms (2)

Treatment A: XCEL-MC-ALPHA/Placebo

EXPERIMENTAL

Single infusion of cryopreserved bone-marrow adult mesenchymal stromal cells followed by placebo infusion at month 6.

Drug: XCEL-MC-ALPHADrug: Placebo

Treatment B: Placebo/XCEL-MC-ALPHA

EXPERIMENTAL

Single infusion of placebo followed by cryopreserved bone-marrow adult mesenchymal stromal cells infusion at month 6.

Drug: XCEL-MC-ALPHADrug: Placebo

Interventions

XCEL-MC-ALPHADRUG

Single infusion

Also known as: Bone-marrow mesenchymal stromal cells
Treatment A: XCEL-MC-ALPHA/PlaceboTreatment B: Placebo/XCEL-MC-ALPHA
PlaceboDRUG

Single infusion

Treatment A: XCEL-MC-ALPHA/PlaceboTreatment B: Placebo/XCEL-MC-ALPHA

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vall Hebron

Barcelona, 08005, Spain

Location

Related Links

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Chronic ProgressiveMultiple SclerosisNervous System DiseasesDemyelinating DiseasesAutoimmune Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xavier Montalban, MD, PhD

    Hospital Vall d'Hebron

    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
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

July 13, 2015

Study Start

May 11, 2015

Primary Completion

November 27, 2017

Study Completion

November 15, 2018

Last Updated

January 21, 2020

Record last verified: 2020-01

Locations

ES(1)