Multiple SclerosisNCT03822858
Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis
A study testing Intrathecal MSC-NP injection in people with Multiple Sclerosis, run by Tisch Multiple Sclerosis Research Center of New York at 1 site in United States.
Trial summary
To give expanded access to intrathecal autologous MSC-NP treatment to patients with progressive MS who do not meet the inclusion/exclusion criteria of our Phase II stem cell trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Intrathecal MSC-NP injection
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- Diagnosis of MS as defined by the McDonald criteria
- Diagnosis of primary progressive or secondary progressive MS
- Patients will be 18 years or older
- Significant disability shown by an Expanded Disability Status Score (EDSS, [5]) ≥4.5 that was not acquired within the last 12 months *(Patients with moderate to severe cerebellar dysfunction who have an EDSS of <6.5 who are not eligible for our Ph II Version Date: 11/21/18 Version #4 9 study will be included. This is because EDSS scores are heavily related to muscle strength and not balance or coordination and most accurately reflect paraparesis. Also there are patients with MS who have disabling upper limb coordination dysfunction but EDSS scores of better than 6.5 who are not suitable for the Phase II study but may benefit from this therapy).
- Stable disease state as evidenced by a lack of gadolinium-enhancing lesions on an MRI and by a stable MRI disease burden (number of T2 lesions and size of lesions) in the last six months and no significant change in EDSS (1 point or more) in the last 12 months
- Does not qualify for the inclusion/exclusion criteria of our Phase II stem cell trial. For example, patients with EDSS >6.5 or MS symptom onset and/or duration of disease >15 years
Who cannot join
- All patients who have had any prior stem cell treatments, including HSCT
- Pregnant or nursing mothers or any woman intending to become pregnant in the next three years
- Use of systemic chemotherapeutic or anti-mitotic medications within three months of study start date due to the possibility of interference with bone marrow procedure
- History of central nervous system infection or immunodeficiency syndromes due to increased risk of CNS infection
- Patients who are anticipated to have difficultly accessing the intrathecal space related to scoliosis, obesity, or any other relevant factors determined by the PI.
- Patients who have not tried available therapies for their progressive MS
Trial locations and contacts
1 site in 1 country.
United States1 site
Tisch MS Research Center of New York
New York, New York, 10019
About this study
Official title: Autologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered Intrathecally
To give expanded access to intrathecal autologous MSC-NP treatment to patients with progressive MS who do not meet the inclusion/exclusion criteria of our Phase II stem cell trial.
- Conditions
- Multiple Sclerosis
- Being tested
- Intrathecal MSC-NP injection
- Keywords
- Mesenchymal Stem Cells, Neural Progenitors, Autologous, Bone Marrow, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MSC-NP injectionDrug
Between 5 to 10 million MSC-NPs will be administered intrathecally in each dose.
10 million cells is the maximum dose. Treatment will consist of 3-5 doses spaced 3 months apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Tisch Multiple Sclerosis Research Center of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saud A Sadiq, MD, FAAN, Principal investigator, Tisch MS Research Center of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822858
- Sponsor's protocol ID
- TISCHMS-MSCNP-003
- Status last verified
- Sep 2026
- First submitted
- 24 Jan 2019
- Last updated
- 25 Sep 2026
- Results posted
- No
Publications
Harris VK, Stark J, Vyshkina T, Blackshear L, Joo G, Stefanova V, Sara G, Sadiq SA. Phase I Trial of Intrathecal Mesenchymal Stem Cell-derived Neural Progenitors in Progressive Multiple Sclerosis. EBioMedicine. 2018 Mar;29:23-30. doi: 10.1016/j.ebiom.2018.02.002. Epub 2018 Feb 3.
PubMed 29449193
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered Intrathecally
- ClinicalTrials.gov ID
- NCT03822858
- Acronym / sponsor ID
- TISCHMS-MSCNP-003
- Conditions
- Multiple Sclerosis
- Keywords
- Mesenchymal Stem Cells, Neural Progenitors, Autologous, Bone Marrow, Multiple Sclerosis
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Tisch Multiple Sclerosis Research Center of New YorkUniversity, hospital or other
- First posted
- 30 Jan 2019 (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.
To give expanded access to intrathecal autologous MSC-NP treatment to patients with progressive MS who do not meet the inclusion/exclusion criteria of our Phase II stem cell trial.
Study design
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of MS as defined by the McDonald criteria
- Diagnosis of primary progressive or secondary progressive MS
- Patients will be 18 years or older
- Significant disability shown by an Expanded Disability Status Score (EDSS, [5]) ≥4.5 that was not acquired within the last 12 months *(Patients with moderate to severe cerebellar dysfunction who have an EDSS of <6.5 who are not eligible for our Ph II Version Date: 11/21/18 Version #4 9 study will be included. This is because EDSS scores are heavily related to muscle strength and not balance or coordination and most accurately reflect paraparesis. Also there are patients with MS who have disabling upper limb coordination dysfunction but EDSS scores of better than 6.5 who are not suitable for the Phase II study but may benefit from this therapy).
- Stable disease state as evidenced by a lack of gadolinium-enhancing lesions on an MRI and by a stable MRI disease burden (number of T2 lesions and size of lesions) in the last six months and no significant change in EDSS (1 point or more) in the last 12 months
Key exclusion criteria (6 listed)
- All patients who have had any prior stem cell treatments, including HSCT
- Pregnant or nursing mothers or any woman intending to become pregnant in the next three years
- Use of systemic chemotherapeutic or anti-mitotic medications within three months of study start date due to the possibility of interference with bone marrow procedure
- History of central nervous system infection or immunodeficiency syndromes due to increased risk of CNS infection
- Patients who are anticipated to have difficultly accessing the intrathecal space related to scoliosis, obesity, or any other relevant factors determined by the PI.
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 |
|---|---|---|
| Intrathecal MSC-NP injectionBetween 5 to 10 million MSC-NPs will be administered intrathecally in each dose. 10 million cells is the maximum dose. Treatment will consist of 3-5 doses spaced 3 months apart. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 29449193Harris VK, Stark J, Vyshkina T, Blackshear L, Joo G, Stefanova V, Sara G, Sadiq SA. Phase I Trial of Intrathecal Mesenchymal Stem Cell-derived Neural Progenitors in Progressive Multiple Sclerosis. EBioMedicine. 2018 Mar;29:23-30. doi: 10.1016/j.ebiom.2018.02.002. Epub 2018 Feb 3.
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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.
Saud A Sadiq, MD, FAAN principal investigator
Tisch MS Research Center of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal MSC-NP injection in people with Multiple Sclerosis, run by Tisch Multiple Sclerosis Research Center of New York at 1 site in United States.
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 6 inclusion and 6 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 25 Sep 2026. 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 United States. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03822858, 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 25 Sep 2026.