COVID-19 관련 급성호흡곤란증후군 치료를 위한 제대혈 유래 중간엽 줄기세포
급성호흡곤란증후군 치료를 위한 제대혈유래 중간엽줄기세포 연구
This is a phase I trial followed by a phase II randomized trial. The purpose of phase I study is the feasibility of treating patients with acute respiratory distress syndrome (ARDS) related to COVID-19 infection (COVID-19) with cord blood-derived mesenchymal stem cells (MSC). The purpose of the phase II trial is to compare the effect of MSC with standard of care in these patients. MSCs are a type of stem cells that can be taken from umbilical cord blood and grown into many different cell types that can be used to treat cancer and other diseases. The MSCs being used for infusion in this trial are collected from healthy, unrelated donors and are stored and grown in a laboratory. Giving MSC infusions may help control the symptoms of COVID-19 related ARDS.
연구 개요
상태
상세 설명
PRIMARY OBJECTIVE:
1. To assess the safety of administering cord blood derived mesenchymal stem cell (CB-MSC) infusions for treatment of moderate, severe or critical pneumonia.
SECONDARY OBJECTIVES:
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In the group of participants who present intubated on ventilator support, assess the proportion that are able to be successfully extubated.
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In the group of participants who present requiring supplemental oxygen but otherwise breathing without assistance, assess the rate of progression to intubation.
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Estimate the survival rate at day 30 post treatment separately by group.
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Determine the treatment effect on clinical parameters, oxygenation and respiratory parameters:
- Resolution of fever
- Changes in oxygen demand (increased oxygen saturation at similar FiO2 or decreased FiO2 requirement)
- Progression to mechanical ventilation
- Length of Mechanical ventilation
- Decrease in PEEP in intubated participants
- Decrease in FiO2 in intubated participants
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Determine the treatment effect on laboratory markers:
- Complete blood count
- CRP
- Ferritin
- D Dimer
- Procalcitonin
- Cytokine levels
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Estimate hospitalization and ICU stay.
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Report on study related adverse events.
OUTLINE:
Currently not shipping cells outside of MD Anderson Cancer Center in Houston.
PILOT STUDY: Patients receive MSCs intravenously (IV) over 1-2 hours on day 1. participants may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.
PHASE II STUDY: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive MSCs IV over 1-2 hours on day 1. Patients may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.
ARM II: Patients receive standard of care.
After completion of study treatment, patients are followed up at days 7, 14, 30, 60, and months 6 and 12.
연구 유형
등록 (추정된)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- M D Anderson Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age greater than or equal 18 years.
- Participants with chest x-ray findings concerning for pneumonia from any cause, with clinical signs suggestive of at least moderate illness such as respiratory rate >20 breaths per minute or with oxygen saturation less than 93% on room air**
- Participants with COVID-19 associated pneumonia must meet baseline categorization of Moderate, Severe or Critical COVID-19 per FDA Guidance for Industry COVID-19: Developing Drugs and Biologics Products for Treatment or Prevention, February 2021.
- Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Participant or legally authorized representative consent. Participants with diminished mental capacity may be allowed on to enroll on the study.
- Because of the nature of COVID-19, participants enrolled on this study with COVID-19 associated pneumonia may have been previously enrolled in other IND trials for their cancer diagnosis or for COVID-19. These enrollments will not exclude them from enrollment to this study.
Exclusion Criteria:
- Moribund participants not expected to survive up to 48 hours
- Participants with severe chronic liver disease (Childs-Pugh score > 10)
- Pregnant and/or lactating women
- Participants on extracorporeal membrane oxygenation
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: Phase II Arm I (mesenchymal stem cells)
Patients receive MSCs as in the Pilot study. |
Given IV
다른 이름들:
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활성 비교기: Phase II Arm II (standard of care)
Patients receive standard of care. |
Receive standard of care
다른 이름들:
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실험적: Pilot study (mesenchymal stem cells)
Patients receive MSCs IV over 1-2 hours on day 1. Patients may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion. |
Given IV
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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3, 4등급 주입 독성 없이 생존한 환자(Phase II)
기간: MSC 주입 후 30일째
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MSC 주입 후 30일째
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3등급 또는 4등급 주입 독성이 있는 살아있는 환자(2상)
기간: MSC 주입 후 30일째
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MSC 주입 후 30일째
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살아 있지 않은 환자(2상)
기간: MSC 주입 후 30일째
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MSC 주입 후 30일째
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Incidence of composite serious adverse events (Phase I)
기간: Within 30 days of the first mesenchymal stem cell (MSC) infusion
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Serious adverse events with be comprised of grade 3 or 4 graft versus host disease or death and will be estimated and reported overall and by group, along with 95% confidence intervals. |
Within 30 days of the first mesenchymal stem cell (MSC) infusion
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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입원 기간(1단계)
기간: MSC 주입 후 최대 30일
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MSC 주입 후 최대 30일
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중환자실 체류(1단계)
기간: MSC 주입 후 최대 30일
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MSC 주입 후 최대 30일
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Proportion of successfully extubated patients who present intubated on ventilator support (Phase I)
기간: Up to day 30 post MSC infusion
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Will be estimated and reported with 95% confidence intervals. |
Up to day 30 post MSC infusion
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Rate of successful progression to intubation in patients who require supplemental oxygen but who are otherwise able to breathe without assistance (Phase I)
기간: Up to day 30 post MSC infusion
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Will be estimated and reported with 95% confidence intervals. |
Up to day 30 post MSC infusion
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Overall survival rate (Phase I)
기간: At day 30 post MSC infusion
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Will be estimated and reported with 95% confidence intervals. |
At day 30 post MSC infusion
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Survival rate in patients who present intubated on ventilator support (Phase I)
기간: At day 30 post MSC infusion
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Will be estimated and reported with 95% confidence intervals. |
At day 30 post MSC infusion
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Survival rate in patients who require supplemental oxygen but who are otherwise able to breathe without assistance (Phase I)
기간: At day 30 post MSC infusion
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Will be estimated and reported with 95% confidence intervals. |
At day 30 post MSC infusion
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Clinical parameters (Phase I)
기간: Up to day 30 post MSC infusion
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The effect of MSCs on clinical parameters will be assessed. Continuous clinical parameters will be summarized by means, medians, standard deviations, ranges, and quartiles. Categorical parameters will be summarized by frequency tables. |
Up to day 30 post MSC infusion
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Oxygenation parameters (Phase I)
기간: Up to day 30 post MSC infusion
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The effect of MSCs on oxygenation parameters will be assessed. Continuous oxygenation parameters will be summarized by means, medians, standard deviations, ranges, and quartiles. Categorical parameters will be summarized by frequency tables. |
Up to day 30 post MSC infusion
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Respiratory parameters (Phase I)
기간: Up to day 30 post MSC infusion
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The effect of MSCs on respiratory parameters will be assessed. Continuous respiratory parameters will be summarized by means, medians, standard deviations, ranges, and quartiles. Categorical parameters will be summarized by frequency tables. |
Up to day 30 post MSC infusion
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Laboratory markers (Phase I)
기간: Up to day 30 post MSC infusion
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The effect of MSCs on laboratory markers will be assessed. Continuous laboratory parameters will be summarized by means, medians, standard deviations, ranges, and quartiles. Categorical parameters will be summarized by frequency tables. |
Up to day 30 post MSC infusion
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Incidence of infusion-related adverse events (Phase I)
기간: Up to day 30 post MSC infusion
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All grades of infusion-related adverse events will be summarized by grade and type. |
Up to day 30 post MSC infusion
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공동 작업자 및 조사자
수사관
- 수석 연구원: Amanda Olson, M.D. Anderson Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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
- 2020-0365
- 2020-0365 (기타 식별자: M D Anderson Cancer Center)
- NCI-2020-06741 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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