- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02801890
Evaluation of Autologous Adipose Derived Mesenchymal Stromal Cells (AD-MSC) Transplantation in Ultra Filtration Failure (UFF)
Autologous AD-MSC Transplantation in Peritoneal Dialysis Patients With Ultra Filtration Failure and Evaluation of Cellular and Molecular Effects of Mesenchymal Stem Cell Infusion on Peritoneal Fibrosis
Peritoneal fibrosis may be occurred as a serious complication of peritoneal dialysis. It's the main factor of UFF that could lead to the Encapsulating Peritoneal Sclerosis (EPS). Using the potential features of MSCs in the treatment of fibrosis may offer new insights into reconstruction the damaged tissues. The project intends to transplant autologous MSCs to ten peritoneal dialysis patients with ultra-filtration failure. It's going to study infusion effects in clinical, cellular and molecular levels.
So in this trial, we will evaluate the effects of this intervention after intravenous injection of autologous adipose derived mesenchymal stem cells in 10 peritoneal dialysis patients with ultra filtration failure (UFF). Fifteen UFF patients are also considered as the control group. Then they will be followed 20, 45 and 90 days, and also 4 and 6 months after first injection.
연구 개요
상세 설명
Chronic kidney disease is defined as a reduced glomerular filtration rate, increased urinary albumin excretion, or both, and is an increasing public health issue. Prevalence is estimated to be 8-16% worldwide. Stage 5 CKD is often called end-stage kidney disease and usually means that the patient requires renal replacement therapy (RRT), which may involve a kidney transplant or a form of dialysis. One of the options in RRT is continuous ambulatory peritoneal dialysis (CAPD). CAPD is characterized by a continuous removal of extracellular fluid by peritoneal membrane. It should be noted that like any other peritoneal dialysis therapy, CAPD has Short or long-term complications and UFF is the most common functional disorder in which the peritoneal ultrafiltration membrane damaged.
This project intends to evaluate, the role of autologous mesenchymal stem cells in improvement of peritoneal membrane function in peritoneal dialysis patients who have ultrafiltration failure up to 6 months.
In this study, 10 male and female subjects who are on peritoneal dialysis for at least two years and have ultrafiltration failure with age range of 18 to 70 years will be enrolled. Patients will be selected from peritoneal dialysis patients attending the peritoneal dialysis ward of Dr. Shariati hospital. The main inclusion criteria is to be on peritoneal dialysis for at least last two years and having Ultrafiltration failure. After obtaining the consent form, a sample of fat tissue will be obtained by a general surgeon under sterilized condition from patients and then in the specialized lab, the mesenchymal stem cells will be separated and cultured to reach appropriate numbers (106/kg). The cells will be injected through peripheral vein in hospital setting. Patients will be followed-up (clinically and laboratory) at baseline and at week 3, week 6, month 3, month 4 and month 6. The clinical assessment and peritoneal function tests will be performed in each visit. Outcome measures: The main outcome measures that periodically will be assessed include: D/P cr, D/P urea, D0/D glucose, PET, KT/V urea, Glomerular filtration rate (GFR)
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Tehran, 이란, 이슬람 공화국
- Royan Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- peritoneal dialysis for at least last two years and
- Ultrafiltration failure
- Both genders
- Age 18-70 years
- inform consent signing
Exclusion Criteria:
- Inability of patients to attend visits and regular testing
- Estimated lifetime less than one year
- Use of immunosuppressive drugs
- Pregnancy
- Malignancy
- Coagulative disorders
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: AD-MSC
The patients with ultra filtration failure (UFF) underwent AD-MSC injection.
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Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .
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위약 비교기: Placebo
The patients with ultra filtration failure (UFF) underwent Placebo injection.
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Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Systemic infection
기간: 6months
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Evaluation the rate of systemic infection in patients with UFF after cell therapy.
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6months
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Hepatic failure
기간: 6 months
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Evaluation the rate of hepatic failure in patients with UFF after cell therapy.
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6 months
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Renal failure
기간: 6 months
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Evaluation the rate of renal failure in patients with UFF after cell therapy.
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Ratio of 4-hour dialysate/plasma creatinine (D/P Cr).
기간: 6 months
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Evaluation the change of (D/P Cr) in patients with UFF after cell therapy.
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6 months
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Ratio of 4-hour dialysate/plasma urea (D/P urea )
기간: 6 months
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Evaluation the change of D/P in patients with UFF after cell therapy.
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6 months
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Ratio of dialysate glucose concentrations (D/D glucose )
기간: 6 months
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Evaluation the change of D/D glucose in patients with UFF after cell therapy.
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6 months
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peritoneal membrane transport function
기간: 6 months
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Assessment of peritoneal membrane transport function by peritoneal equilibration test (PET)
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6 months
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Glomerular filtration rate (GFR):
기간: 6 months
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Evaluation the change of Glomerular filtration rate (GFR) in patients with UFF after cell therapy.
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6 months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Soroosh Shekarchian, MD, Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
- 연구 책임자: Nasser Aghdami, MD,PhD, Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
- 연구 책임자: Gholamreza Pourmand, MD, Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.
- 연구 책임자: Iraj Najafi, MD, Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.
- 수석 연구원: Sudabeh Alatab, MD, Sudabeh
- 수석 연구원: Reza Moghadasali, PhD, Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Royan-kidney-006
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
Ultra Filtration Failure에 대한 임상 시험
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The Catholic University of Korea알려지지 않은골관절염, UC(Ultra-Congruent) 삽입물
Intravenous injection에 대한 임상 시험
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China Academy of Chinese Medical SciencesNational Natural Science Foundation of China모병
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Shanghai Junshi Bioscience Co., Ltd.모집하지 않고 적극적으로
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Shanghai University of Traditional Chinese Medicine알려지지 않은
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North American Institute for Continuing Medical...완전한
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Bispebjerg Hospital완전한
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Samsung Medical Center빼는