A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients : A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.This is a multi-center, randomized, placebo-controlled, dose-finding study comparing the efficacy, safety and tolerability of different dosing regimens of Allocetra-OTS, in patients with sepsis. The study aims to compare the safety and efficacy of different doses and regimens of Allocetra-OTS, as well as the clinical manifestations following Allocetra-OTS treatment, to that of Placebo in the treatment of organ failure in adult sepsis patients..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 13. März Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: November 3, 2020, Last downloaded: ClinicalTrials.gov processed this data on March 20, 2024, Last updated: March 20, 2024 |
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| Study ID: |
NCT04612413 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG000097012 |
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| 245 | 1 | 0 | |a A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients |b A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: November 3, 2020, Last downloaded: ClinicalTrials.gov processed this data on March 20, 2024, Last updated: March 20, 2024 | ||
| 520 | |a Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.This is a multi-center, randomized, placebo-controlled, dose-finding study comparing the efficacy, safety and tolerability of different dosing regimens of Allocetra-OTS, in patients with sepsis. The study aims to compare the safety and efficacy of different doses and regimens of Allocetra-OTS, as well as the clinical manifestations following Allocetra-OTS treatment, to that of Placebo in the treatment of organ failure in adult sepsis patients. | ||
| 650 | 2 | |a Infections | |
| 650 | 2 | |a Communicable Diseases | |
| 650 | 2 | |a Sepsis | |
| 650 | 2 | |a Toxemia | |
| 650 | 2 | |a Urinary Tract Infections | |
| 650 | 2 | |a Intraabdominal Infections | |
| 650 | 2 | |a Cholangitis | |
| 650 | 2 | |a Cholecystitis | |
| 650 | 2 | |a Cholecystitis, Acute | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Active, not recruiting | |
| 650 | 4 | |a Phase: Phase 2 | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2024) vom: 13. März |
| 773 | 1 | 8 | |g year:2024 |g day:13 |g month:03 |
| 856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT04612413 |z kostenfrei |3 Volltext |
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