Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden

NCT ID: NCT03778333

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-01
• Study Completion Date: 2016-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open label single arm study

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.

Group Type: EXPERIMENTAL

Autologous mesenchymal stem cells

Intervention Type: BIOLOGICAL

IV therapy with autologous bone-marrow derived mesenchymal stem cells

Interventions

Autologous mesenchymal stem cells

IV therapy with autologous bone-marrow derived mesenchymal stem cells

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of MS

1. 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.

2. 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.

3. 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.

2. Age_ 18-65 years

3. Disease duration: 2-20 years

4. EDSS 3,0-7,0

2. Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization

3. Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization

4. Treatment with corticosteroids within the 30 days prior to randomization

5. Relapse occurred during the 60 days prior to randomization

6. 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

7. Severely limited life expectancy by another co-morbid illness

8. Active or chronic severe infection.

9. History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts

10. Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)

11. eGFR < 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.

12. Inability to give written informed consent in accordance with research ethics board guidelines

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Lou Brundin

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Karolinska Institute, Karolinska University Hospital Solna

Stockholm, , Sweden

Karolinska Institute, Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

MSC-progressive MS

Identifier Type: -

Identifier Source: org_study_id