Clinical trial NCT01228266: Mesenchymal Stem Cell Transplantation in MS
Official title: Autologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2010-10-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Inflammatory forms of MS

   1. Relapsing-remitting MS (RRMS) patients
   2. Secondary progressive MS (SPMS) patients with continued relapses
   3. Primary progressive MS (PPMS) patients with enhancing MRI lesions and positive CSF (oligoclonal banding)
2. Age 18-50 years
3. Disease duration \>= 2 and \>= 10 years
4. EDSS 3.0 - 6.5
5. Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by:

   1. 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
   2. \>= 1 moderate-severe relapses in past 18 months
   3. \>= 1 Gadolinium enhancing lesions (double or triple dose Gadolinium)
   4. \>= 1 new T2 lesion
   5. For PPMS only, \>= 1 Gadolinium enhancing lesions
6. Has given informed consent to participate in the study.

Exclusion Criteria:

1. SPMS without ongoing relapses
2. PPMS without positive CSF or Gadolinium enhancing lesions
3. \<= 3 months since treatment with any immunosuppressive therapy
4. \<=1 month since last treatment with interferon-B or glatiramer acetate
5. Corticosteroid treatment \<= 30 days
6. Relapse \<= 60 days
7. History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C
8. Any metallic or electronic device that precludes from undergoing MRI
9. Pregnancy or lactation
10. Current treatment with an investigational therapy

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Neurology Service, Hospital Clinic de barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Albert Saiz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.