Autologous, Bone Marrow-Derived Mesenchymal Stem Cell-Derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo; Administered Intrathecally

Tisch Multiple Sclerosis Research Center of New York1 个研究点分布在 1 个国家开始时间: 2019年1月30日最近更新: 2025年8月17日

适应症

试验速览

阶段: 不适用
状态: Available
发起方
试验地点: 1

研究概览入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Expanded Access

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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

研究者

发起方

Tisch Multiple Sclerosis Research Center of New York

申办方类型

Other

责任方

Sponsor

研究点 (1)

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