무면허 제대혈 장치에서 세포 집단 주입
For the next 5-10 years or possibly longer, a high proportion of the Cord Blood Banks (CBB) inventory worldwide will be composed of unlicensed umbilical cord blood (UCB) units. While Food and Drug Administration (FDA)-licensed units will be prioritized, it will always be possible that an unlicensed unit will have known attributes, making it a better source of cells for the given indication. Because of the wide variety of current and potential indications as a source of cells for hematopoietic reconstitution or other form of cellular therapy, it is critical that the investigators have access to unlicensed UCB units.
연구 개요
상세 설명
Patients will receive intravenous hydration, acetaminophen and diphenhydramine hydrochloride (or appropriate alternative regimen) approximately 30 minutes prior to UCB infusion with doses adjusted for subject age and weight unless otherwise specified in the specific treatment protocol. Additional treatments will vary with the specific use of the UCB cells as specified in institutional review board (IRB)-approved disease-specific protocols at the University of Minnesota.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- 모병
- Masonic Cancer Center, University of Minnesota
-
연락하다:
- Claudio Brunstein, MD
- 전화번호: 612-625-3918
- 이메일: bruns072@umn.edu
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수석 연구원:
- Claudio Brunstein, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
To be eligible for an unlicensed umbilical cord blood (UCB) unit, the subject must meet each of the eligibility criteria listed below:
- Subjects with any diagnosis for which there is an institutional review board (IRB) approved treatment protocol that requires UCB as a source of hematopoietic stem cells for lympho-hematopoietic reconstitution after myeloablative or non myeloablative conditioning.
- Subject (or parent/guardian) must provide written informed consent for the use of unlicensed UCB units with co-enrollment onto a University of Minnesota IRB-approved clinical trial that details the disease specific treatment plan that prescribes the use of UCB as source of cells
- Subject has an unlicensed UCB unit that meets required cell dose and HLA matching criteria (as defined in the primary treatment protocol) that is considered negative for tested blood-borne pathogens and also lack an 'equivalent', licensed UCB unit from a University of Minnesota approved Cord Blood Bank
Exclusion Criteria:
- Exclusion criteria are specified in the treatment protocol according to indication.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Unlicensed Umbilical Cord Blood Infusion
All patients will be registered in OnCore under this protocol as well as the specific treatment protocol.
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Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units.
기간: Within 24 Hours Post Infusion
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Documentation of events for the purpose of this study will only be for those events at least possibly related to the unlicensed UCB. Monitoring for acute infusional toxicities will end 24 hours after the umbilical cord blood (UCB) infusion. |
Within 24 Hours Post Infusion
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units
기간: Up to Day 180
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point estimations and 95% confidence intervals of serious infusion reaction |
Up to Day 180
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|
Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units
기간: Prior to Infusion
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Upon thawing (e.g., number of CD34 and colony forming cells for hematopoietic products or number of CD4+/CD25+/CD127- cells for Treg products prior to further manipulation). |
Prior to Infusion
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Incidence of Mislabeled UCB Units
기간: Up to Day 180
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Point estimations and 95% confidence intervals of incidences mislabeled UCB units |
Up to Day 180
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Comparison of Specific Cord Blood Banks (CBBs)
기간: Up to Day 180
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Determine if bacterial contamination, poor cell recoveries, shipment of mislabeled units, blood borne pathogen transmission or serious infusion reactions are more prevalent in units from specific CBBs. |
Up to Day 180
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Alex Hoover, MD, MSc, Masonic Cancer Center, University of Minnesota
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 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .