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Study funding was terminated.
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In this study the investigators wish to test the hypothesis that treatment with Lemtrada is associated with alterations in immune homeostasis in favor of multiple regulatory leukocyte populations which persist long after completion of the treatment phase. Specifically, the investigators propose that regulatory B-cells are induced rapidly following the first course of treatment with Lemtrada, that this occurs prior to induction of other regulatory populations, and that these cells are functionally capable of regulating immune responses. The investigators also propose that there is a concomitant induction of functional regulatory T-cells and alternatively-activated monocytes during the first year after treatment giving a "blanket" enhanced regulatory immune profile. This study is designed primarily to identify possible mechanisms by which Lemtrada acts to modify the immune environment in recipient patients, as such the "outcome" measures are all immunological.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lemtrada treated - 6 month | Patients that received their first course of treatment with Lemtrada approximately 6 months prior. |
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| Lemtrada treated - 12 month | Patients that received their first course of treatment with Lemtrada approximately 12 months prior but who have not received the second course of treatment. |
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| Lemtrada treated - 18 month | Patients that received their first course of treatment with Lemtrada approximately 18 months prior and their second course of treatment with Lemtrada approximately 6 months prior. |
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| Lemtrada treated - 24 month | Patients that received their first course of treatment with Lemtrada approximately 24 months prior and their second course of treatment with Lemtrada approximately 18 months prior and who have not received any further treatment. |
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| Lemtrada qualified - untreated | Patients that are qualified to start treatment with Lemtrada but have not yet being untreated. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of leukocyte function. | Other | The function and phenotype of regulatory B-cells, regulatory T-cells and alternatively-activated monocytes will be assessed directly ex vivo from PBMC. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess changes in the circulating regulatory B-cell population. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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We will recruit 125 individuals with clinically definite MS, defined by the revised McDonald criteria (35). Patients in each cohort will be enrolled from those currently being seen by physicians at the University of Southern California, Department of Neurology.
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| Name | Affiliation | Role |
|---|---|---|
| Brett T Lund, Ph.D. | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California, Department of Neurology | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34777337 | Derived | Kashani N, Kelland EE, Vajdi B, Anderson LM, Gilmore W, Lund BT. Immune Regulatory Cell Bias Following Alemtuzumab Treatment in Relapsing-Remitting Multiple Sclerosis. Front Immunol. 2021 Oct 28;12:706278. doi: 10.3389/fimmu.2021.706278. eCollection 2021. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Plasma and serum.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |