Multiple SclerosisPhase 1NCT03069170
Autologous Bone Marrow Derived Stem Cells for the Treatment of Multiple Sclerosis.
A Phase 1 study testing Stem Cell Transplantation in people with Multiple Sclerosis, run by Stem Cells Arabia at 1 site in Jordan.
Trial summary
Until now, there is no effective approach to stop the progression of multiple sclerosis and stimulate re-myelination. Autologous stem cell transplantation shows hope and is quickly developing as an alternative therapy. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Stem Cell Transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJordan
- Study dates
- Jul 2016to Jan 2021
- Phase
- Phase 1
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsing-remitting MS (RRMS) patients
- Age 18-50 years
- Disease duration >= 2 and <= 10 years
- EDSS: 3.0 - 6.5
Who cannot join
- RRMS not fulfilling inclusion criteria
- SPMS or PPMSTreatment with any immunosuppressive therapy
- Treatment with interferon-beta or glatiramer acetate within the 30 days prior to transplantation
- Treatment with corticosteroids within the 30 days prior to transplantation
- Relapse occurred during the 60 days prior to transplantation
- History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C
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- Pregnancy or risk of pregnancy/ lactation
- Current treatment with an investigational therapy
- Inability to give written informed consent in accordance with research ethics board guidelines
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Stem Cells Arabia
Amman, 11953
Adeeb AlZoubi, PhD, 00962795337575, adeebalzoubi@stemcellsarabia.net
About this study
Official title: Safety and Efficacy of Immuno-modulation and Autologous Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Multiple Sclerosis.
Until now, there is no effective approach to stop the progression of multiple sclerosis and stimulate re-myelination. Autologous stem cell transplantation shows hope and is quickly developing as an alternative therapy. We propose the use of autologous bone marrow-derived specific stem cell populations and mesenchymal stem cell transplantation (BM-MSC) associated with immuno-modulation to treat patients with relapsing-remitting MS (RRMS).
Read the detailed description
Multiple sclerosis (MS) is an autoimmune de-myelinating disease in which the myelin sheaths of nerve cells in the central nervous system are damaged.This damage disrupts the ability of parts of the nervous system to communicate, resulting in a range of signs and symptoms, including physical, mental, and psychiatric issues. To date, There is no known cure for multiple sclerosis. Treatments attempt to improve function after an attack and prevent new attacks.
Stem cells possess strong immunomodulatory properties that are shown to play a role in the maintenance of peripheral tolerance and in the control of autoimmunity and that may stimulate repair and regeneration of lesion. Clinical studies have shown that stem cells can be safely harvested and do not form tumors. Most of human stem cell trials have focused on clinical applications for haematopoietic stem cells (HSC), mesenchymal stem cells (MSC), or both. When administered intravenously they have an immune inhibitory effect that can ameliorate animal autoimmune diseases. MSC transplantation significantly improves clinical outcome in experimental allergic encephalitis (EAE). When administered intravenously, MSC may migrate to inflammatory brain lesions and promote survival of nervous cells. Hence, MSC have become the focus of studies as a potential cell therapy for stimulating neuro-protection in human neurodegenerative diseases such as MS.
We propose a safety and efficacy trial of a intravenous and intrathecal injections of autologous bone marrow-derived stem cells into patients with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Stem Cell Transplantation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem Cell TransplantationBiological
Intravenous and Intrathecal injections of purified autologus bone marrow-derived stem cells.
| Study group | Role | What they receive |
|---|---|---|
| Stem Cells | Experimental | Intravenous administration of purified autologous bone marrow-derived stem cells. Receives: Biological: Stem Cell Transplantation |
| Stem Cell Transplantation | Experimental | Intrathecal administration of purified autolgous bone-marrow derived stem cells. Receives: Biological: Stem Cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness assessment by MRI
Measured: 6 months
Safety assessment by physical examination, vital signs, analytical results, electrocardiograph monitoring, and Expanded Disability Status Scale (EDSS)
Measured: 12 months
Secondary outcomes (3)
Change in Quality of life by Multiple Sclerosis Quality of Life (MSQOL-54)
Measured: 6 months
Axonal effect by Optical coherence tomography (OCT)
Measured: 6 months
Immunology: Dosing of G, A and M immunoglobulins, and complement factors C3 and C4
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study startJul 2016
- Primary completionSep 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stem Cells Arabia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069170
- Sponsor's protocol ID
- SCA-MS1
- Status last verified
- Jun 2019
- First submitted
- 25 Feb 2017
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Immuno-modulation and Autologous Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT03069170
- Acronym / sponsor ID
- SCA-MS1
- Conditions
- Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stem Cells ArabiaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 3 Mar 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.
Until now, there is no effective approach to stop the progression of multiple sclerosis and stimulate re-myelination. Autologous stem cell transplantation shows hope and is quickly developing as an alternative therapy. We propose the use of autologous bone marrow-derived specific stem cell populations and mesenchymal stem cell transplantation (BM-MSC) associated with immuno-modulation to treat patients with relapsing-remitting MS (RRMS).
Detailed description
Multiple sclerosis (MS) is an autoimmune de-myelinating disease in which the myelin sheaths of nerve cells in the central nervous system are damaged.This damage disrupts the ability of parts of the nervous system to communicate, resulting in a range of signs and symptoms, including physical, mental, and psychiatric issues. To date, There is no known cure for multiple sclerosis. Treatments attempt to improve function after an attack and prevent new attacks.
Stem cells possess strong immunomodulatory properties that are shown to play a role in the maintenance of peripheral tolerance and in the control of autoimmunity and that may stimulate repair and regeneration of lesion. Clinical studies have shown that stem cells can be safely harvested and do not form tumors. Most of human stem cell trials have focused on clinical applications for haematopoietic stem cells (HSC), mesenchymal stem cells (MSC), or both. When administered intravenously they have an immune inhibitory effect that can ameliorate animal autoimmune diseases. MSC transplantation significantly improves clinical outcome in experimental allergic encephalitis (EAE). When administered intravenously, MSC may migrate to inflammatory brain lesions and promote survival of nervous cells. Hence, MSC have become the focus of studies as a potential cell therapy for stimulating neuro-protection in human neurodegenerative diseases such as MS.
We propose a safety and efficacy trial of a intravenous and intrathecal injections of autologous bone marrow-derived stem cells into patients with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stem Cells | Experimental | Biological: Stem Cell TransplantationIntravenous administration of purified autologous bone marrow-derived stem cells. |
| Stem Cell Transplantation | Experimental | Biological: Stem Cell TransplantationIntrathecal administration of purified autolgous bone-marrow derived stem cells. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Relapsing-remitting MS (RRMS) patients
- Age 18-50 years
- Disease duration >= 2 and <= 10 years
- EDSS: 3.0 - 6.5
Key exclusion criteria (9 listed)
- RRMS not fulfilling inclusion criteria
- SPMS or PPMSTreatment with any immunosuppressive therapy
- Treatment with interferon-beta or glatiramer acetate within the 30 days prior to transplantation
- Treatment with corticosteroids within the 30 days prior to transplantation
- Relapse occurred during the 60 days prior to transplantation
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 |
|---|---|---|
| Stem Cell TransplantationIntravenous and Intrathecal injections of purified autologus bone marrow-derived stem cells. | Biological | Stem Cell Transplantation, Stem Cells |
Primary outcome
Effectiveness assessment by MRI
Time frame: 6 months
Safety assessment by physical examination, vital signs, analytical results, electrocardiograph monitoring, and Expanded Disability Status Scale (EDSS)
Time frame: 12 months
3 secondary outcomes
Change in Quality of life by Multiple Sclerosis Quality of Life (MSQOL-54)
Time frame: 6 months
Axonal effect by Optical coherence tomography (OCT)
Time frame: 6 months
Immunology: Dosing of G, A and M immunoglobulins, and complement factors C3 and C4
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stem Cell Transplantation in people with Multiple Sclerosis, run by Stem Cells Arabia at 1 site 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 9 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: status not confirmed, as of the sponsor's last update on 17 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 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adeeb AlZoubi, PhD (00962795337575, adeebalzoubi@stemcellsarabia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness assessment by MRI (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2020.