Clinical Study of UCB Combined With UC-MSCs in the Treatment of Bone Marrow Failure Disorders
NCT ID: NCT05794425
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2023-08-01
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cyclosporine A
Cyclosporine A
3-5 mg per kilogram per day.
UCB+UC-MSCs
Umbilical cord blood & Umbilical cord derived mesenchymal stem cells
Intravenous infusion of umbilical cord blood and umbilical cord derived mesenchymal stem cells (5-8×10\^7) at 1 week interval.
Interventions
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Cyclosporine A
3-5 mg per kilogram per day.
Umbilical cord blood & Umbilical cord derived mesenchymal stem cells
Intravenous infusion of umbilical cord blood and umbilical cord derived mesenchymal stem cells (5-8×10\^7) at 1 week interval.
Eligibility Criteria
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Inclusion Criteria
2. Patients with no severe impairment of liver and kidney function (total bilirubin (TBIL): ≤ 1.5×ULN; ALT or AST: ≤ 2.5×ULN; Alkaline phosphatase: ≤ 3×ULN; Serum creatinine: ≤ 1.5×ULN);
3. The prothrombin time (PT) or activated partial thrombin time (APTT) or international normalized ratio (INR): ≤ 1.5×ULN in the absence of anticoagulant therapy;
4. The left ventricular ejection fraction (LVEF): ≥50% by cardiac echocardiography
5. Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) were negative. If any of the above items is positive, the HBV DNA titer in peripheral blood must be lower than the detection limit or 1×10\^3 copys/ml;
6. Patients with no plans for stem cell transplantation;
7. Patients with ECOG 0-2;
8. Those who voluntarily participate in this clinical study and have signed an informed consent .
Exclusion Criteria
2. Patient with severe cardiac insufficiency (e.g. grade Ⅲ、Ⅳ by NYHA classification NYHA), and medically uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥110 mmHg);
3. Patients with severe mental illness;
4. Patients with clinically significant infection should be recruited with delay;
5. AST or ALT: above 3 times the upper limit of normal, creatinine, total bilirubin, or alkaline: phosphatase (ALP): above 1.5 times the upper limit of normal;
6. Patients with test positive for HIV, HCV or syphilis;
7. Patients with severe allergies or allergic to the active ingredients, excipients of the drug, or blood products in this clinical trials;
8. Patients who are pregnant or breastfeeding, or have a childbirth plan in the near future;
9. Patients receive allogeneic/autologous hematopoietic stem cell transplantation by the assessment of investigators;
10. There are other conditions that the investigators consider inappropriate for inclusion.
ALL
No
Sponsors
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Shandong Province Third hospital
OTHER
Dezhou People's Hospital
OTHER
Children's Hospital Affiliated to Shandong University
UNKNOWN
The Second Affiliated Hospital of Shandong First Medical University
OTHER
Tai'an Central Hospital
UNKNOWN
Linyi People's Hospital
OTHER
Rizhao People's Hospital
OTHER
Lanling People's Hospital
UNKNOWN
Jining First People's Hospital
OTHER
Jining Medical University
OTHER
Zibo Municipal Hospital
OTHER
Binzhou People's Hospital
OTHER
The Affiliated Hospital of Binzhou Medical College
UNKNOWN
Shengli Oilfield Hospital
OTHER
Weihai Municipal Hospital
OTHER
Weihai Central Hospital
OTHER
Shandong University of Traditional Chinese Medicine
OTHER
Gansu Provincial Hospital of Traditional Chinese Medicine (TCM)
UNKNOWN
Wuwei People's Hospital
UNKNOWN
Gansu Wuwei Tumor Hospital
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
Yuncheng Institute of Hematology
UNKNOWN
Kaifeng Central Hospital
OTHER
Zhengzhou Central Hospital
OTHER
Air Force Hospital of Western War Zone
UNKNOWN
The First People' s Hospital of Yunnan Province
UNKNOWN
Zigong No.1 Peoples Hospital
OTHER
The First People's Hospital of Jingzhou
OTHER
Jiangxi Province Children's Hospital
OTHER
Second Affiliated Hospital of Zhengzhou University
OTHER
Yantai Ludong Hospital (Shandong Provincial Hospital Group)
UNKNOWN
Shandong Qilu Stem Cells Engineering Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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zhe Yu, MD
Role: PRINCIPAL_INVESTIGATOR
Shandong Province Third hospital
Locations
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Shandong Provincial Third Hospital
Jinan, Shandong, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China
Jining first people's Hospital
Jining, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Rizhao People's Hospital
Rizhao, Shandong, China
Tai'an Central Hospital
Tai’an, Shandong, China
Weihai Municipal Hospital
Weihai, Shandong, China
Yantai Ludong Hospital (Shandong Provincial Hospital Group)
Yantai, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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zhe Yu, MD
Role: primary
yuan Fang, MD
Role: primary
haiguo Zhang
Role: primary
yu Xu
Role: primary
jun Guo
Role: primary
guanchen Bai
Role: primary
xiuzhi Deng
Role: primary
xiaolei Wang, MD
Role: primary
Other Identifiers
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UCB&MSCs-BMF-2023
Identifier Type: -
Identifier Source: org_study_id