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| Name | Class |
|---|---|
| Mount Sinai Hospital, New York | OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
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This study evaluates the effect of erythropoietin on the number and function of regulatory T cells in adults with autoimmune hepatitis. Participants will receive a single dose of erythropoietin, and then the investigators will collect blood at different time points for analysis of regulatory T cell number and function.
There is data from the laboratory that erythropoietin helps stimulate regulatory T cells, a type of immune cell which is thought to combat autoimmunity, but this study will look at whether it does the same thing in adults with autoimmune hepatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Single dose of erythropoietin 10,000 units to be administered subcutaneously at time of enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythropoietin | Drug | Subcutaneous injection of erythropoietin 10,000 units |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of regulatory T cells | Calculated relative to baseline collected at time of enrollment | At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of effector T cells after a single dose of erythropoietin | Calculated relative to baseline collected at time of enrollment | At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks. |
| Change in cytokine production by the T cells in response to ex vivo stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medicine | Chicago | Illinois | 60611 | United States | ||
| Mount Sinai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33721837 | Derived | McEachern E, Carroll AM, Fribourg M, Schiano TD, Hartzell S, Bin S, Cravedi P, Levitsky J. Erythropoietin administration expands regulatory T cells in patients with autoimmune hepatitis. J Autoimmun. 2021 May;119:102629. doi: 10.1016/j.jaut.2021.102629. Epub 2021 Mar 13. |
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| ID | Term |
|---|---|
| D019693 | Hepatitis, Autoimmune |
| ID | Term |
|---|---|
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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Calculated relative to baseline collected at time of enrollment |
| At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks. |
| New York |
| New York |
| 10029 |
| United States |
| D001327 |
| Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |