Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis

NCT04749667 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 159326
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of the study is to investigate neuroregenerative efficacy (proof of concept) of intrathecal treatment with autologous MSCs as measured by neurophysiological parameters in patients with progressive MS. Secondary objectives are to assess neuroregenerative efficacy as measured by other neurophysiological parameters as well as clinical, opthalmological and MRI modalities, and to assess safety of the treatment procedure.

Conditions

Multiple Sclerosis; Progressive Multiple Sclerosis

Keywords

Mesenchymal stem cells; Multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• Neurophysiological parameters - Combined evoked potentials

  Somatosensoric evoked potentials (SEP) + visual evoked potentials (VEP) + motor evoked potentials (MEP), latency (ms) and amplitude (mV)

  6 months

Secondary Outcomes (12)

• Neurophysiological parameters - Somatosensoric evoked potantials

  6 and 12 months

• Neurophysiological parameters - Motor evoked potentials

  6 and 12 months

• Neurophysiological parameters - Visual evoked potentials

  6 and 12 months

• MRI-Lesion volumes

  6 and 12 months

• MR- Brain volumes

  6 and 12 months

Study Arms (2)

Arm A - Crossover with MSCs at baseline and placebo at 6 months

EXPERIMENTAL

Receives mesenchymal stem cells at baseline and placebo at 6 months

Other: MSCs; Drug: Saline

Arm B - Crossover with placebo at baseline and MSCs at 6 months

EXPERIMENTAL

Receives placebo at baseline and mesenchymal stem cells at 6 months

Other: MSCs; Drug: Saline

Interventions

MSCs OTHER

Autologous bone-marrow derived mesenchymal stem cells

Also known as: Mesenchymal stem cells

Arm A - Crossover with MSCs at baseline and placebo at 6 months; Arm B - Crossover with placebo at baseline and MSCs at 6 months

Saline DRUG

Isotonic saline

Arm A - Crossover with MSCs at baseline and placebo at 6 months; Arm B - Crossover with placebo at baseline and MSCs at 6 months

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 to ≤55, both genders
• Diagnosis of secondary progressive or primary progressive MS using revised McDonald criteria of clinically definite MS
• An EDSS score of 4 to 7
• Disease duration 2 - 15 years
• Signed, written informed consent

You may not qualify if:

• Any illness or prior/ongoing treatment that in the opinion of the investigators would jeopardize the ability of the patient to tolerate autologous stem cell treatment
• Any ongoing infection, including Tbc, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV or syphilis infections, as well as heaptitis B surface antigen positivity and/or hepatitis C PCR positivity
• Current immunomodulatory/immunosuppressive treatment
• Current treatment with fampridin
• History of 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
• History of previous diagnosis of myelodysplasia or previous hematologic disease (including lymphoproliferative disease, bone marrow insufficiency or previous lymphoid irradiation) or current clinically relevant abnormalities of white blood cell counts
• Immunocompromised patients
• Estimated glomerular filtration rate \<60 ml/min/1.73 m2 or known renal failure
• Bleeding or clotting diathesis or the use of antithrombotic or anticoagulative treatment
• Platelet (thrombocyte) count \<100 x 10\*9/L
• Participation in another experimental clinical study within the preceding 12 months
• Contraindications to MRI
• Prior or current major depression
• Prior or current psychiatric illness, mental deficiency or cognitive dysfunction influencing the patient ability to make an informed consent or comply with the treatment and follow-up phases of this protocol.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator
• University Hospital Ulm: collaborator
• University Hospital, Akershus: collaborator
• University Hospital of North Norway: collaborator
• St. Olavs Hospital: collaborator

Study Sites (4)

Akershus university hospital

Lørenskog, Akershus, Norway

Location

University hospital of North Norway

Tromsø, Troms Og Finnmark, Norway

Location

St.Olav university hospital

Trondheim, Trøndelag, Norway

Location

Haukeland University Hospital

Bergen, Vestland, Norway

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Christopher Elnan Kvistad, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Lars Bø, Prof

  Haukeland University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, placebo-controlled, cross-over study

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: February 11, 2021
• Study Start: August 9, 2021
• Primary Completion: March 24, 2025
• Study Completion (Estimated): March 15, 2027
• Last Updated: March 12, 2026

Record last verified: 2025-03

Locations

NO (4)