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| Name | Class |
|---|---|
| Iltoo Pharma | INDUSTRY |
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The purpose of this study is to demonstrate the ability of low dose IL-2 to stimulate peripheral blood Tregs of women with unexplained repeated early spontaneous miscarriages for development of a therapy to prevent fetal rejection by low dose IL-2.
About 1 to 3% of women of childbearing age have repeated early spontaneous miscarriages that may be related to parental chromosomal abnormalities, uterine abnormalities, hormonal causes, infectious etiology, thrombophilia ... When one of these known causes is excluded, it is unexplained miscarriages of which half would be due to an immunological deregulation of the mother causing a decrease of the tolerance to the fetus.
In this context, the stimulation of regulatory T cells (Tregs) by low dose IL-2 is a therapeutic option with a rational, preclinical and clinical data very favorable.
In humans, low dose IL-2 allows preferential activation of Tregs and is very well tolerated. Several therapeutic trials have shown its efficiencies.
These elements make it possible to envisage the development of a therapeutic to prevent fetal rejection by IL2-fd on the women with spontaneous miscarriages by an immunological deregulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Low-dose IL-2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose IL-2 | Drug | Subcutaneous injection of low dose of IL-2 for induction course of 5 days, the 10th day after the beginning of periods. At most 5 courses of low dose of IL-2. |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total) | Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2 | At the day 38 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1] |
| Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total) | Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2 | At the day 66 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1 |
| Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total) | Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2 | At the day 94 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1 |
| Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total) | Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2 | At the day 122 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1 |
| Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total) | Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2 | At the day 150 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of rate of blood circulating T regulator lymphocytes(expressed in absolute numbers) | Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2 | At the day 38 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Klatzmann, Pr | Pitié Salpètrière APHP Paris | Principal Investigator |
| Arsene Mékinian, Dr | Saint Antoine APHP Paris | Study Director |
| Gilles Kayem, Pr | Trousseau APHP Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mekinian | Paris | Hopital Saint Antoine | 75012 | France | ||
| Bornes |
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| ID | Term |
|---|---|
| D000026 | Abortion, Habitual |
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
| Variation of rate of blood circulating T regulator lymphocytes(expressed in absolute numbers) |
Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2 |
| At the day 66 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1 |
| Variation of rate of blood circulating T regulator lymphocytes(expressed in absolute numbers) | Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2 | At the day 94 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1 |
| Variation of rate of blood circulating T regulator lymphocytes(expressed in absolute numbers) | Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2 | At the day 122 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1 |
| Variation of rate of blood circulating T regulator lymphocytes(expressed in absolute numbers) | Change of Tregs at Day 14 of cycles under low dose of IL-2 compared to the baseline of the first cycle without low dose of IL-2 | At the day 150 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 11 |
| Paris |
| Hopital Tenon |
| 75020 |
| France |
| Kayem | Paris | Hopital Trousseau | 75012 | France |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |