임상 레이더 AI | ||
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임상시험 NCT06731192 (HUCMSC)은(는) 알포트 증후군에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Human Umbilical Cord Mesenchymal Stem Cells for Alport Syndrome (HUCMSC) 2상, 3상 40 무작위 배정 위약 대조
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06731192 (HUCMSC)은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 알포트 증후군에 대해 진행되며, 2상 3상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2025년 1월 1일부터 가능하며, 40명의 참여자를 모집할 예정입니다. Guangzhou Women and Children's Medical Center이(가) 진행하는 이 연구는 2028년 12월 31일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 12월 31일에 갱신되었습니다.
간단한 개요
The goal of this clinical trial is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in the treatment of Alport syndrome (AS) in a randomized, single-blind, placebo-controlled trial, to provide a clinical basis for the development of stem cell products for the treatment of AS, and to further clarify the therapeutic effect of hUC-MSC in the treatment of AS.
공식 제목
Human Umbilical Cord Mesenchymal Stem Cells for Alport Syndrome: Α Prospective Randomized, Single-blind, Placebo-controlled, Single-center Clinical Trial
질환명
알포트 증후군기타 연구 식별자
- HUCMSC
- [2022]00100-3
- MR-44-24-042448 (기타 보조금/자금 번호) (National Health Commission of the People's Republic of China)
NCT 번호
실제 연구 시작일
2025-01-01
최신 업데이트 게시
2024-12-31
예상 연구 완료일
2028-12-31
계획된 등록 인원
40
연구종류
중재연구
단계/상
2상
3상
3상
상태
대상자모집전
키워드
Alport syndrome
Human Umbilical Cord Mesenchymal Stem Cells
Randomized Clinical Trial
Human Umbilical Cord Mesenchymal Stem Cells
Randomized Clinical Trial
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적MSC Theatment Conventional symptomatic supportive treatment and human umbilical cord mesenchymal stem cells treatment | hUC-MSC This group of patients received a total of 2 peripheral intravenous Human umbilical cord mesenchymal stem cells (hUC-MSC) infusions during the treatment period on the basis of conventional symptomatic and supportive treatment. The interval between the two infusions was 14 days, and the single infusion dose was approximately 2×1000,000 cells/Kg.
Conventional clinical treatment refers to symptomatic treatment with ACE...더 보기 |
위약 대조군Placebo Control Conventional symptomatic supportive treatment and normal saline as a placebo control | Placebo control drug This group of patients received a total of 2 intravenous infusions of normal saline (the same volume, specifications and batches used in the experimental group) as a placebo control during the treatment period on the basis of conventional symptomatic and supportive treatment. The interval between the two infusions was 14 days.
Conventional clinical treatment refers to symptomatic treatment with ACEI and ARB drugs. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Urine protein remission rate | Follow-up was performed at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, and 12 months after the last hUC-MSC infusion. Urinalysis, 24-hour urine protein quantification, and urine protein/creatinine ratio were tested to evaluate the remission of urine protein after treatment. | 2 weeks to 12 months after treatment |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Hematuria remission rate | Follow-up was performed at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, and 12 months after the last hUC-MSC infusion. The urine abnormal red blood cell count of the children was tested to evaluate the remission of hematuria after treatment. | 2 weeks to 12 months after treatment |
Renal function improvement rate | Follow-up was performed at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, and 12 months after the last hUCMSC infusion to measure the serum creatinine, blood urea nitrogen, serum cystatin C, glomerular filtration rate and other indicators of the children to evaluate the improvement of renal function after treatment. | 2 weeks to 12 months after treatment |
참여 도우미
적격성 기준
연령대
어린이
최소 연령
3 Years
참여 가능한 성별
전체
- 3 years old ≤Age ≤ 12 years old;
- Meet the diagnostic criteria of Alport syndrome;
- Positive proteinuria or combined hematuria;
- Chronic kidney disease (CKD) stage: I-III stage children, that is, glomerular filtration rate greater than 60 ml/min.1.73m2;
- No history of infectious diseases within 1 week before treatment;
- Negative infectious disease screening;
- No allergic state and related clinical manifestations;
- Signed informed consent (children or their families).
- Age <3 years or >12 years old;
- Alport syndrome patients with only microscopic hematuria and normal glomerular filtration rate;
- Patients with significantly reduced renal function, chronic kidney disease stage IV or V, Alport syndrome;
- Patients with other renal diseases;
- Have a history of severe allergic reactions or be allergic to 2 or more foods or drugs;
- Known allergy to stem cells or stem cell-derived products or ingredients in stem cell preparations;
- Have severe heart, liver, lung and other organ dysfunction or have tumors;
- Those with developmental malformations of the urinary system;
- Those with autoimmune diseases and regular use of immunosuppressants;
- Those with serious infectious diseases that are not under control;
- Those with a history of infectious diseases such as HBV, HCV, HIV, syphilis;
- History of surgery or acute trauma or blood loss exceeding 200ml within 3 months;
- Participated in other clinical studies within 3 months;
- Have received any cell product or derivative product treatment within 12 months;
- Other circumstances that the researcher deems inappropriate for inclusion.
Guangzhou Women and Children's Medical Center연구 대표 연락처
연락처: Xia Gao, 86-020-81330569, [email protected]
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