Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-05 @ 11:47 AM
Study NCT ID:
NCT03822858
Status:
AVAILABLE
Last Update Posted:
2025-08-17
First Post:
2019-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2019-01-24', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Mesenchymal Stem Cells', 'Neural Progenitors', 'Autologous', 'Bone Marrow', 'Multiple Sclerosis'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '29449193', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of MS as defined by the McDonald criteria\n* Diagnosis of primary progressive or secondary progressive MS\n* Patients will be 18 years or older\n* 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).\n* 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\n* 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\n\nExclusion Criteria:\n\n* All patients who have had any prior stem cell treatments, including HSCT\n* Pregnant or nursing mothers or any woman intending to become pregnant in the next three years\n* 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\n* History of central nervous system infection or immunodeficiency syndromes due to increased risk of CNS infection\n* Patients who are anticipated to have difficultly accessing the intrathecal space related to scoliosis, obesity, or any other relevant factors determined by the PI.\n* Patients who have not tried available therapies for their progressive MS'}, 'identificationModule': {'nctId': 'NCT03822858', 'briefTitle': 'Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Tisch Multiple Sclerosis Research Center of New York'}, 'officialTitle': 'Autologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered Intrathecally', 'orgStudyIdInfo': {'id': 'TISCHMS-MSCNP-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intrathecal MSC-NP injection', 'type': 'DRUG', 'description': 'Between 5 to 10 million MSC-NPs will be administered intrathecally in each dose.\n\n10 million cells is the maximum dose. Treatment will consist of 3-5 doses spaced 3 months apart.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Saud Sadiq, MD', 'role': 'CONTACT', 'email': 'ssadiq@tischms.org', 'phone': '212 265 8070'}, {'name': 'Saud A. Sadiq, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tisch MS Research Center of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Saud A Sadiq, MD, FAAN', 'role': 'CONTACT', 'email': 'ssadiq@tischms.org', 'phone': '212 265 8070'}, {'name': 'Violaine Harris, PhD', 'role': 'CONTACT', 'email': 'vharris@tischms.org', 'phone': '212 265 8070'}], 'overallOfficials': [{'name': 'Saud A Sadiq, MD, FAAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tisch MS Research Center of New York'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tisch Multiple Sclerosis Research Center of New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}