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Trial record 33 of 75 for:    stem cell multiple sclerosis

Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03822858
Expanded Access Status : Available
First Posted : January 30, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Tisch Multiple Sclerosis Research Center of New York

Brief 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.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Intrathecal MSC-NP injection

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: Autologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered Intrathecally

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Intrathecal MSC-NP injection

    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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822858


Contacts
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Contact: Saud A Sadiq, MD, FAAN 212 265 8070 atahir@tischms.org
Contact: Alifiya Tahir, BDS, MPH 212 265 8070 atahir@tischms.org

Locations
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United States, New York
Tisch MS Research Center of New York
New York, New York, United States, 10019
Contact: Alifiya Tahir, BDS, MPH    212-265-8070    atahir@tischms.org   
Principal Investigator: Saud A. Sadiq, MD         
Sponsors and Collaborators
Tisch Multiple Sclerosis Research Center of New York
Investigators
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Principal Investigator: Saud A Sadiq, MD, FAAN Tisch MS Research Center of New York

Additional Information:
Publications:
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Responsible Party: Tisch Multiple Sclerosis Research Center of New York
ClinicalTrials.gov Identifier: NCT03822858     History of Changes
Other Study ID Numbers: TISCHMS-MSCNP-003
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Keywords provided by Tisch Multiple Sclerosis Research Center of New York:
Mesenchymal Stem Cells
Neural Progenitors
Autologous
Bone Marrow
Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases