- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01711788
Intrabone Infusion of Umbilical Cord Blood Stem Cells
A New Approach to Improve Long-term Hematopoietic Recovery After Allogeneic Umbilical Cord Blood Transplantation in Children - Intrabone Infusion of Umbilical Cord Blood Stem Cells
연구 개요
상세 설명
Umbilical cord blood transplantation (UCBT) has been increasingly used to treat malignant and non-malignant haematological, immunodeficiency and some metabolic diseases. UCBT offers the advantages of easy procurement, no risk to donors, a reduced risk of transmitting infections, immediate availability of cryopreserved units, and acceptable partial HLA mismatches. However, patients treated with UCBT show delayed hematopoietic and immunological recoveries, have higher rates of infection, and relapse from the original malignant disease, which can all lead to life threatening problems. UCBT can also result in a higher rate of graft failure compared to other hematopoietic stem cell transplantation (HSCT) sources. The problem of a slower hematopoietic recovery post-UCBT has been addressed using a number of different approaches in adult patients.In adults, use of intrabone injection of cord blood results in a faster hematopoietic recovery in a phase II study. However, there is no clinical trial in pediatric patients.
This study is addressed to determine if a change in the cord blood stem cell infusion method can increase and accelerate hematopoietic reconstitution after UCBT in pediatric patients.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
Quebec
-
Montreal, Quebec, 캐나다, H3C1T5
- Centre Hospitalier Universitaire Sainte-Justine
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- One to 21 years of age;
- More than 10 kg in weight;
- Diagnosis of hematopoietic disorders (malignant or not) with an indication for hematopoietic stem cell transplantation;
- Absence of an HLA-identical related donor;
- Availability of a single cord blood (CB) with at least 3 x 10^7 nucleated cells (NCs)/kg (if HLA identical or 1 HLA-mismatch) or at least 4 x 10^7 NCs/kg (if a 2 HLA-mismatch) at freezing. Use of two CB units ("double cord transplant") will be allowed provided that: 1) a single CB unit fulfilling the above criteria is not available; 2) a maximum of 2 HLA mismatch is present for each CB unit; and 3) a minimum of 4 x 10^7 NCs/kg (as the sum for both CB units) is present at freezing.
- A myeloablative-conditioning regimen;
- A Lansky (for patients less than 16 years of age) or Karnofsky (for patients more than 16 years of age) score equal to or higher than 70%.
- Adequate organ function as follows:
- Cardiac (ejection fraction > 50%);
- Renal (serum creatinine within the normal range for age, and creatinine clearance or a GFR > 70 ml/min/1.73m2);
- Hepatic (AST or ALT < 5 x upper limit of normal for age);
- Pulmonary (FEV1, FVC, and DLCO ≥ 50% by pulmonary function tests or, in children unable to cooperate, no sign of dyspnea at rest, no exercise intolerance, no supplementary oxygen therapy, and a normal pulmonary radiography or pulmonary scan);
- No sign of uncontrolled systemic bacterial, fungal or viral infection;
- Written informed consent by the patient or his/her legal guardian
Exclusion Criteria:
- Non-myeloablative conditioning;
- Pregnancy or breastfeeding;
- HIV positive serology;
- Bone disease (e.g. osteopetrosis, osteogenesis imperfecta)
- Previous autologous or allogeneic hematopoietic stem cell transplantation performed up to one year before enrolment, except in the case of non-engraftment or early rejection of a previous allogeneic stem cell transplantation.
- Active skin infection at the site of intrabone injection.
- History of intolerance/allergy to sedation medications or local anesthetics.
- Contraindication to sedation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Intrabone umbilical cord blood tranplant
Intrabone infusion of umbilical cord blood stem cells
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Platelet recovery rate
기간: at 100 days post- transplantation
|
First of seven days of untransfused platelet count higher than 20 x 10^9/L
|
at 100 days post- transplantation
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Neutrophil recovery rate
기간: at 60 days post- transplantation
|
First of three days of absolute neutrophil count equal or higher than 0.5 x 10^9/L
|
at 60 days post- transplantation
|
Immunological reconstitution
기간: at 30, 60, 100, 180, and 360 days post- transplantation
|
Total number of T cells (and subpopulations), B and NK (natural killer) cells in peripheral blood at different time-points
|
at 30, 60, 100, 180, and 360 days post- transplantation
|
Donor chimerism rate
기간: at 30, 60,100, and 180 days post-transplantation
|
Percentage of donor(s) cells in peripheral blood at different time-points
|
at 30, 60,100, and 180 days post-transplantation
|
Acute GVHD (grade 2-4) rate
기간: at 180 days
|
Incidence of grade II-IV acute GVHD (Graft versus Host Disease)
|
at 180 days
|
Infection rate (bacterial, viral, fungal and parasitic)
기간: at 180 days post-transplantation
|
Clinical and microbiological documented infections will be reported according to anatomic site, date of onset and microorganism
|
at 180 days post-transplantation
|
Event-free and overall survival
기간: at 2 years
|
Event-free survival is defined as the time interval between transplantation and relapse, graft rejection, death or last follow-up, whichever occurs first; Overall survival is defined as the time between transplantation and death or last follow-up
|
at 2 years
|
Adverse infections (grade and frequency)
기간: at one month post-transplantation
|
Toxicity will be assessed using the Common Terminology Criteria for Adverse Events v4.0
|
at one month post-transplantation
|
chronic GVHD
기간: at 2 years post-transplantation
|
Incidence of chronic GVHD (Graft versus Host Disease) will be scored according to NIH consensus on chronic GVHD
|
at 2 years post-transplantation
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Henrique Bittencourt, MD, PhD, St. Justine's Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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. .
Intrabone infusion of umbilical cord blood stem cells에 대한 임상 시험
-
Restem, LLC.완전한