Multiple SclerosisPhase 1/2NCT03326505
Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment
A Phase 1/2 study testing Umbilical cord derived Mesenchymal Stem Cells and Supervised physical therapy in people with Multiple Sclerosis, run by University of Jordan at 2 sites in Jordan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Umbilical cord derived Mesenchymal Stem Cells and Supervised physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesJordan
- Study dates
- 25 Sep 2017to 20 Feb 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
2 sites in 1 country.
Jordan2 sites
Cell Therapy Center, University of Jordan
Amman, 11942
Cell Therapy Center
Amman, 11942
About this study
Official title: The Effect of Stem Cell Therapy and Comprehensive Physical Therapy in Motor and Non-Motor Symptoms in Patients With Multiple Sclerosis: A Comparative Study.
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.
Read the detailed 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
- Conditions
- Multiple Sclerosis
- Being tested
- Umbilical cord derived Mesenchymal Stem Cells, Supervised physical therapy
- Keywords
- Umbilical Cord Mesenchymal Stem Cells, Multiple Sclerosis, Neuroimmunology, Autoimmune disease, Physical therapy
- Medical subject headings
- Multiple Sclerosis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord derived Mesenchymal Stem CellsBiological
Also called UC-MSCs
Allogenic umbilical cord derived stem cells which are to be injected intrathecally as a treatment option for consenting MS patients
Supervised physical therapyOther
Also called SPT
A combined physical therapy program of Balance, strengthening and endurance exercises
| Study group | Role | What they receive |
|---|---|---|
| Injection of Umbilical cord derived UC- MSCs | Active comparator | Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients Receives: Biological: Umbilical cord derived Mesenchymal Stem Cells |
| injection of UC- MSCs and SPT | Active comparator | Allogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients along with a supervised physical therapy program Receives: Biological: Umbilical cord derived Mesenchymal Stem Cells; Other: Supervised physical therapy |
| Supervised Physical Therapy (SPT) | Active comparator | Supervised physical therapy program without stem cells Receives: Other: Supervised physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isolation and Expansion of Mesenchymal Stem Cells
To isolate stem cells from UC: first, the cord will be cut into small pieces around (4-5cm) and washed with phosphate buffered saline, then the umbilical vein and the two arteries will be removed.These pieces will be placed in culture plate and cultured in UC-MSCs medium consist of; alpha modification of Minimum Essential Medium (α-MEM) supplemented with 10% fetal bovine serum, 1% glutamine, 1% penicillin/streptomycin and 1 μg/mL amphotericin B.After incubation period the undigested tissue will be discarded and nucleated cells will be pelleted by centrifugation at 450xg for 10 minutes. Cell pellet will be re-suspended in UC-MSCs culture medium, cultured in tissue culture flasks and placed in CO2 incubator at 37°C, 5% CO2. Cells will be expanded in multilayer cell factory tissue culture flasks to reach an estimated 108 UC-MSCs that will be frozen in bags of 106 cells for subsequent thawing and administration.
Measured: 3-6 months
Secondary outcomes (4)
Safety and Efficacy Assessment Pre and Post Treatment
Outcome measures will be assessed at 3 months pre-treatment, baseline (prior injections), 3 months, 6 months, and 12 months.
Informed consent will be obtained in writing from each subject prior to participation in the study. If the subject is unable to give consent or he/she scores less than 24 on the Mini Mental Status Examination (MMSE), they will be excluded from the study. The research personnel involved in the study will carefully explain the consent form to the subject. The subject will then be given ample opportunity to ask questions prior agreeing to participate. If the need arises the research personnel will be available to answer questions and address any concerns.
Measured: 3-12 months
Motor Functions Assessments
A number of motor function tests will be performed with every follow up visit for all 30 patients.
Measured: 3-12 months
Measuring Non-motor outcomes to assess treatment efficacy.
Clinical Tests ,all patients will be evaluated clinically using qualitative and quantitative tests.
Measured: 3-6 months
Biological Assessments
Blood samples will be collected pre and post treatment for immediate or ulterior analysis. Results will be compared between individuals and then between the two groups that received one or two doses of UC-MSCs.
Measured: 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start25 Sep 2017
- Primary completion25 Jan 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Jamali, University of Jordan
- Investigators
- Abdallah Awidi, MD, Study director, Cell Therapy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326505
- Sponsor's protocol ID
- ALLOMSUJCTC
- Status last verified
- Feb 2020
- First submitted
- 9 May 2017
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alghwiri AA, Jamali F, Aldughmi M, Khalil H, Al-Sharman A, Alhattab D, Al-Radaideh A, Awidi A. The effect of stem cell therapy and comprehensive physical therapy in motor and non-motor symptoms in patients with multiple sclerosis: A comparative study. Medicine (Baltimore). 2020 Aug 21;99(34):e21646. doi: 10.1097/MD.0000000000021646.
PubMed 32846775
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stem Cell Therapy and Comprehensive Physical Therapy in Motor and Non-Motor Symptoms in Patients With Multiple Sclerosis: A Comparative Study.
- ClinicalTrials.gov ID
- NCT03326505
- Acronym / sponsor ID
- ALLOMSUJCTC
- Conditions
- Multiple Sclerosis
- Keywords
- Umbilical Cord Mesenchymal Stem Cells, Multiple Sclerosis, Neuroimmunology, Autoimmune disease, Physical therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 25 Jan 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Injection of Umbilical cord derived UC- MSCs | Active comparator | Biological: Umbilical cord derived Mesenchymal Stem CellsAllogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients |
| injection of UC- MSCs and SPT | Active comparator | Biological: Umbilical cord derived Mesenchymal Stem Cells, Other: Supervised physical therapyAllogenic Umbilical Cord derived stem cells injected intrathecally to enrolled MS patients along with a supervised physical therapy program |
| Supervised Physical Therapy (SPT) | Active comparator | Other: Supervised physical therapySupervised physical therapy program without stem cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical cord derived Mesenchymal Stem CellsAlso: UC-MSCsAllogenic umbilical cord derived stem cells which are to be injected intrathecally as a treatment option for consenting MS patients | Biological | Injection of Umbilical cord derived UC- MSCs, injection of UC- MSCs and SPT |
| Supervised physical therapyAlso: SPTA combined physical therapy program of Balance, strengthening and endurance exercises | Other | Supervised Physical Therapy (SPT), injection of UC- MSCs and SPT |
Primary outcome
Isolation and Expansion of Mesenchymal Stem Cells
Time frame: 3-6 months
To isolate stem cells from UC: first, the cord will be cut into small pieces around (4-5cm) and washed with phosphate buffered saline, then the umbilical vein and the two arteries will be removed.These pieces will be placed in culture plate and cultured in UC-MSCs medium consist of; alpha modification of Minimum Essential Medium (α-MEM) supplemented with 10% fetal bovine serum, 1% glutamine, 1% penicillin/streptomycin and 1 μg/mL amphotericin B.After incubation period the undigested tissue will be discarded and nucleated cells will be pelleted by centrifugation at 450xg for 10 minutes. Cell pellet will be re-suspended in UC-MSCs culture medium, cultured in tissue culture flasks and placed in CO2 incubator at 37°C, 5% CO2. Cells will be expanded in multilayer cell factory tissue culture flasks to reach an estimated 108 UC-MSCs that will be frozen in bags of 106 cells for subsequent thawing and administration.
4 secondary outcomes
Safety and Efficacy Assessment Pre and Post Treatment
Time frame: 3-12 months
Motor Functions Assessments
Time frame: 3-12 months
Measuring Non-motor outcomes to assess treatment efficacy.
Time frame: 3-6 months
Biological Assessments
Time frame: 3-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 32846775Alghwiri AA, Jamali F, Aldughmi M, Khalil H, Al-Sharman A, Alhattab D, Al-Radaideh A, Awidi A. The effect of stem cell therapy and comprehensive physical therapy in motor and non-motor symptoms in patients with multiple sclerosis: A comparative study. Medicine (Baltimore). 2020 Aug 21;99(34):e21646. doi: 10.1097/MD.0000000000021646.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdallah Awidi, MD study director
Cell Therapy Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Umbilical cord derived Mesenchymal Stem Cells and Supervised physical therapy in people with Multiple Sclerosis, run by University of Jordan at 2 sites in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isolation and Expansion of Mesenchymal Stem Cells (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03326505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.