Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-25

Study Completion Date

2020-02-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Effectiveness of BM-MSC vs AT-MSC in the Treatment of SCI Patients.

NCT02981576

Spinal Cord Injuries

COMPLETED PHASE1/PHASE2

Intrathecal Transplantation of UC-MSC in Patients With Sub-Acute Spinal Cord Injury

NCT03521336

Spinal Cord Injury

UNKNOWN PHASE2

Intrathecal Transplantation of UC-MSC in Patients With Early Stage of Chronic Spinal Cord Injury

NCT03521323

Spinal Cord Injuries

UNKNOWN PHASE2

Study of Alternative Exercise Therapies for Progressive Multiple Sclerosis (MS)

NCT01097538

Multiple Sclerosis

COMPLETED NA

Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis

NCT06552611

Multiple Sclerosis

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Injection of Umbilical cord derived UC- MSCs

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

Group Type ACTIVE_COMPARATOR

Umbilical cord derived Mesenchymal Stem Cells

Intervention Type BIOLOGICAL

Allogenic umbilical cord derived stem cells which are to be injected intrathecally as a treatment option for consenting MS patients

injection of UC- MSCs and SPT

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

Group Type ACTIVE_COMPARATOR

Umbilical cord derived Mesenchymal Stem Cells

Intervention Type BIOLOGICAL

Allogenic umbilical cord derived stem cells which are to be injected intrathecally as a treatment option for consenting MS patients

Supervised physical therapy

Intervention Type OTHER

A combined physical therapy program of Balance, strengthening and endurance exercises

Supervised Physical Therapy (SPT)

Supervised physical therapy program without stem cells

Group Type ACTIVE_COMPARATOR

Supervised physical therapy

Intervention Type OTHER

A combined physical therapy program of Balance, strengthening and endurance exercises

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Umbilical cord derived Mesenchymal Stem Cells

Allogenic umbilical cord derived stem cells which are to be injected intrathecally as a treatment option for consenting MS patients

Intervention Type BIOLOGICAL

Supervised physical therapy

A combined physical therapy program of Balance, strengthening and endurance exercises

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

UC-MSCs SPT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No