Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden

NCT03778333 | Completed Phase 1

• 1 other identifier: MSC-progressive MS
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

To assess the safety of a single dose of IV infusion of bone-marrow derived autologous Mesenchymal Stem Cells (MSCs) in Multiple Sclerosis (MS) with progressive disease status.

Conditions

Autologous Mesenchymal Stem Cells; Multiple Sclerosis

Keywords

Mesenchymal Stem Cells; Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• To evaluate number of participants with an adverse event related to the treatment.

  Adverse events is defined as any untoward or undesirable medical occurence in the form of signs, symptoms, abnormal findings or diseases that emerge during the study period, regardless of causal relationship to the study drug.

  48 weeks

• To evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions.

  Brain MRI examination

  48 weeks

Secondary Outcomes (2)

• To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale).

  48 weeks

• To evaluate effect on peripheral blood immune cell populations.

  24 weeks

Study Arms (1)

Open label single arm study

EXPERIMENTAL

All patients will be treated with 1 single dose of IV infusion of autologous bone-marrow derived mesenchymal stem cells (1-2 million cells/kg body weight) and their therapeutic response will be followed over 48 weeks.

Biological: Autologous mesenchymal stem cells

Interventions

Autologous mesenchymal stem cells BIOLOGICAL

IV therapy with autologous bone-marrow derived mesenchymal stem cells

Open label single arm study

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of MS
• Active relapsing remitting MS (RRMS) as evidenced by presence of ≥ 1 clinically documented relapse in the past 12 months or ≥2 clinically documented relapses in the last 24 months.
• Secondary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year or evidenced by ≥1 relapse or ≥ GEL at MRI performed within the last year.
• Primary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year.
• Age\_ 18-65 years
• Disease duration: 2-20 years
• EDSS 3,0-7,0

You may not qualify if:

• Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
• Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
• Treatment with corticosteroids within the 30 days prior to randomization
• Relapse occurred during the 60 days prior to randomization
• Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year
• Severely limited life expectancy by another co-morbid illness
• Active or chronic severe infection.
• History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts
• Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)
• eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.
• Inability to give written informed consent in accordance with research ethics board guidelines

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (2)

Karolinska Institute, Karolinska University Hospital Solna

Stockholm, 171 76, Sweden

Location

Karolinska Institute, Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Open-label phase 1, single-center, pre-post comparison study

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: December 19, 2018
• Study Start: December 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 31, 2016
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

SE (2)