- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04366271
Clinical Trial of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With COVID-19 (MESCEL-COVID19)
Phase II Clinical Trial to Explore the Efficacy of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With Severe Pulmonary Involvement by COVID-19
The disease caused by the SARS-CoV-2 virus is a viral disease that infects the lungs, producing flu-like symptoms. Elderly infected patients and/or those with co-morbidities may suffer from acute respiratory distress syndrome due to pneumonia (COVID-19 disease). Given the high transmission, this virus has spread in recent months from Wuhan (China) to the whole world, becoming a global emergency pandemic. The lack of curative treatment for this disease justifies the need to carry out clinical trials that provide quality evidence on treatment options. Given the pathophysiology of the disease, which involves an uncontrolled inflammatory response of alveolar cells, a treatment that attenuates the cytokine cascade could be key in rescuing the patient's lung tissue. Mesenchymal cells, due to their immunoregulatory potential and regenerative capacity, can be an effective treatment for patients infected with the SARS-CoV-2 virus.
In the present study we propose a therapy with undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue, a treatment whose safety has already been described in other clinical trials and that shows promising results in pilot studies carried out in China.
연구 개요
연구 유형
단계
- 2 단계
연락처 및 위치
연구 장소
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Barakaldo, 스페인, 48903
- Hospital Universitario de Cruces
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Madrid, 스페인, 28006
- Hospital Universitario de la Princesa
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Madrid, 스페인, 28009
- Hospital Infantil Universitario Nino Jesus
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Madrid, 스페인, 28034
- Hospital Ramon y Cajal
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Madrid, 스페인, 28046
- Complejo Universitario La Paz
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Madrid
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Getafe, Madrid, 스페인, 28320
- Hospital Universitario de Getafe
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients aged between 40 and 80 years
- Body weight between 50 kg and 100 kg
- PCR diagnosis of SARS-CoV-2 virus infection
Clinical diagnosis of severe lung involvement associated with SARSCoV- 2 virus infection according to the criteria of the National Health Commission of China, that is, patients who meet at least one of the following criteria:
- Respiratory distress with ≥ 30 breaths per minute; or
- Oxygen saturation ≤ 93% at baseline; or
- Partial arterial oxygen pressure (PaO2) / Fraction of inspiration of O2 (FiO2) ≤300mmHg. (PaO2 / FiO2 is accepted based on SatO2). Patients who do not require respiratory support, or who require noninvasive respiratory support (conventional, high-flow oxygen therapy, or non-invasive mechanical ventilation) are considered eligible.
- Patients who are already receiving the standard medical treatment available for severe lung involvement associated with SARS-CoV-2 virus infection or any of the standard treatments are contraindicated in the patient and cannot be used and it is necessary to consider other alternatives.
- Women who are surgically sterile or postmenopausal or women of childbearing potential with negative urine or serum pregnancy test or men willing to use condoms for the entire duration of the study or for three months after the last dose of the investigational drug, whichever is later, or have a partner who is using a contraceptive method with high efficacy, such as described above.
- Signed informed consent.
Exclusion Criteria:
Clinical diagnosis of critically serious lung involvement associated with SARS-CoV-2 virus infection according to the criteria of the National Health Commission of China, that is, patients who meet any of the following criteria:
- Respiratory failure requiring invasive mechanical ventilation; or
- Shock; or
- Combination with failure of another organ; need for ICU admission for monitoring / treatment.
- Patients who are expected to develop rapidly fatal disease within 72 hours of enrollment.
- Inability to maintain a mean arterial pressure > 50 mmHg before selection despite the presence of vasopressors and intravenous fluids.
- Patients requiring treatment with vasopressors (dopamine > 5 mg / kg / min or any dose of epinephrine, norepinephrine, phenylephrine, or vasopressin) for at least 2 hours to maintain systolic blood pressure (SBP) > 90 mmHg (or mean blood pressure [MBP] > 70 mmHg) after adequate fluid administration.
- Patients who are not expected to live more than 3 months due to other medical illnesses, such as neoplasia or other terminal illnesses.
- Patients with primary or metastatic lung cancer or with chemotherapy scheduled for the next 90 days.
- Patients with a known primary immunodeficiency disorder or with acquired immunodeficiency syndrome (HIV infection) with a CD4 count <200 cells / mm3 or who do not have an undetectable viral load (<200 copies).
- Patients receiving immunosuppressive therapy (including chronic treatment with any alpha antitumor necrosis factor [TNFa]) or corticosteroid therapy.
- Granulocytopenia, not due to sepsis, evidenced by an absolute neutrophil count <500 per μL.
- Hematologic or lympho-reticular malignancies, unless in remission.
- Patients who have received a stem cell, organ, or bone marrow transplant in the last 6 months.
- Patients in current treatment with a biological product (eg, antibodies, cell therapy) or with plasmapheresis in the last 8 weeks.
- Patients who are currently receiving or have received another investigational drug in the 90 days prior to study initiation (or 5 halflives of the investigational compound, whichever is longer).
- Known allergies or hypersensitivity to antibiotics and/or any component of the investigational product.
- Patients with known severe liver function impairment.
- Patients with known severe kidney function impairment.
- Patients admitted in the previous 15 days for causes other than SARS-CoV-2 virus infection.
- Diseases other than SARS-CoV-2 virus infection leading to New York Heart Association class IV status.
- Terminal neuromuscular disorders that alter the gradual withdrawal of the ventilator (eg, amyotrophic lateral sclerosis).
- Patients with complete tetraplegia (traumatic or otherwise).
- Dementia-Alzheimer and another situation in which is considered patient can not understand what is explaining, can not read or does not understand the language.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Mesenchymal cells
Undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue
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1 infusion of undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue
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활성 비교기: 치료의 표준
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Best treatment option for COVID-19 according to investigator criteria
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mortality due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment
기간: 28 days
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Percentage of patients death due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment
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28 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Mortality due to lung involvement due to SARS-CoV-2 virus infection at 14 days of treatment
기간: 14 days
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Percentage of patients death due to lung involvement due to SARS-CoV-2 virus infection at 14 days of treatment
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14 days
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Mortality from any cause at 28 days
기간: 28 days
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Percentage of patients death due to any cause at 28 days of treatment
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28 days
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Days without mechanical respirator and without vasopressor treatment for 28 days
기간: 28 days
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Number of days without mechanical respirator and without vasopressor treatment for 28 days
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28 days
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Patients alive without mechanical ventilation and without vasopressors on day 28
기간: 28 days
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Percentage of patients alive without mechanical ventilation and without vasopressors on day 28
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28 days
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Patients alive and without mechanical ventilation on day 14
기간: 14 days
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Percentage of patients alive and without mechanical ventilation on day 14
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14 days
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Patients alive and without mechanical ventilation on day 28
기간: 28 days
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Percentage of patients alive and without mechanical ventilation on day 28
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28 days
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Patients alive and without vasopressors on day 28
기간: 28 days
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Percentage of patients alive and without vasopressors on day 28
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28 days
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Days without vasopressors for 28 days
기간: 28 days
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Number of days without vasopressors for 28 days
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28 days
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Patients cured at 15 days
기간: 15 days
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Percentage of patients cured at 15 days
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15 days
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Incidence of Treatment-Emergent Adverse Events
기간: 1 year
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Percentage of patients with each adverse event
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1 year
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공동 작업자 및 조사자
수사관
- 연구 의자: Luis Madero, MD, Hospital Infantil Universitario Niño Jesús, Oncohematology Department
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MESCEL-COVID19
- 2020-001450-22 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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