Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden

Multiple Sclerosis Clinical Trial

Official title:

Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778333
• Other study ID #: MSC-progressive MS
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2012
• Est. completion date: December 31, 2016

Study information

• Verified date: May 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 31, 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Exclusion Criteria:

1. Subtype of MS not fulfilling inclusion criteria

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

Related Conditions & MeSH terms

• Autologous Mesenchymal Stem Cells
• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Sclerosis

Intervention

Biological:
• Autologous mesenchymal stem cells
IV therapy with autologous bone-marrow derived mesenchymal stem cells

Locations

Country	Name	City	State
Sweden	Karolinska Institute, Karolinska University Hospital	Stockholm
Sweden	Karolinska Institute, Karolinska University Hospital Solna	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions.	Brain MRI examination	48 weeks
Secondary	To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale).	EDSS assessed by neurologist.	48 weeks
Secondary	To evaluate effect on peripheral blood immune cell populations.	Peripheral blood samples.	24 weeks