Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment

University of Jordan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Sclerosis

Treatments: Biological: Umbilical cord derived Mesenchymal Stem Cells; Other: Supervised physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03326505

ALLOMSUJCTC

Details and patient eligibility

About

This study aims at expanding Umbilical Cord derived Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice and study its efficacy when compared to a Supervised Physical Therapy Program alone.

Full description

Umbilical cord derived MSCs bank will be generated and all patients given the same cells from the same biological sample.

Thorough clinical, cognitive and motor analysis will be performed at baseline and compared to outcomes at 3 different time points of all enrolled patients.

The study will consist of three arms: 1- Stem cells treatment 2- Stem cells and supervised physical therapy 3- Supervised physical therapy

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A clinical diagnosis of definite MS according to the revised McDonald Criteria.
• Expanded Disability Status Scale (EDSS) ≤ 7
• Failure of standard medical therapy
• Disease duration of at least three years prior to enrollment.

Exclusion criteria

• Pregnant and lactating women
• Previous treatment with immunosuppressive agents in the last 12 months prior to enrollment
• Recent MS relapse in the month prior to enrollment
• Treatment with oral or parenteral steroids for any cause in the month prior to enrollment
• Significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders
• Previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment
• Any contra-indication for magnetic resonance imaging (MRI) or gadolinium contrast.
• Positive serology for HIV, Hepatitis B or Hepatitis C
• Any history of malignancy or exposure to radiation at any time prior to enrollment
• Any contra-indication to lumbar puncture
• Severe cognitive impairment that would interfere with the patient's ability to understand and sign the informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 3 patient groups

Injection of Umbilical cord derived UC- MSCs

Active Comparator group

Description:

Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients

Treatment:

Biological: Umbilical cord derived Mesenchymal Stem Cells

injection of UC- MSCs and SPT

Active Comparator group

Description:

Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients along with a supervised physical therapy program

Treatment:

Other: Supervised physical therapy

Biological: Umbilical cord derived Mesenchymal Stem Cells

Supervised Physical Therapy (SPT)

Active Comparator group

Description:

Supervised physical therapy program without stem cells

Treatment:

Other: Supervised physical therapy