Mesenchymal Stem Cells for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation
NCT ID: NCT06171906
Last Updated: 2023-12-15
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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NOT_YET_RECRUITING
PHASE4
68 participants
INTERVENTIONAL
2024-01-01
2028-11-01
Brief Summary
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Poor graft function (PGF) following transplantation, which refers to inadequate engraftment of the transplanted hematopoietic stem cells, is one of the major factors limiting the effectiveness of allo-HSCT. Mesenchymal stromal cells (MSCs), identified within the bone marrow stroma, are a type of non-hematopoietic multipotent stem cells. Several studies, including previous research by our research team, suggest that MSCs can improve the bone marrow hematopoietic microenvironment by secreting various cytokines. This leads to the promotion of hematopoietic stem cell proliferation and differentiation, enhancement of hematopoietic function, and support for hematopoiesis as well as direct or indirect promotion of vascular regeneration in damaged tissues and organs.
Therefore, exploring the efficacy of umbilical cord-derived MSCs in treating poor graft function after allo-HSCT, observing the recovery of blood parameters in patients with poor engraftment, monitoring transplantation-related complications and immune reconstitution, and conducting preliminary investigations into the underlying mechanisms can contribute to the exploration of new clinical techniques for the treatment of PGF following allo-HSCT.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MSCs treatment group
mesenchymal stromal cells
On the basis of conventional PGF treatment for poor implantation, the enrolled patients were injected with 1×10\^6/kg mesenchymal stem cells of cord blood weekly for 4 consecutive weeks
Interventions
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mesenchymal stromal cells
On the basis of conventional PGF treatment for poor implantation, the enrolled patients were injected with 1×10\^6/kg mesenchymal stem cells of cord blood weekly for 4 consecutive weeks
Eligibility Criteria
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Inclusion Criteria
2. No gender limit, age ≥18 years old and ≤60 years old;
3. KPS score \>60 points, expected survival period \>3 months;
4. Those without serious functional damage to important organs throughout the body;
5. The patient has no other contraindications to hematopoietic stem cell transplantation
6. Voluntary test and informed consent.
Exclusion Criteria
2. Those combined with other malignant tumors need treatment;
3. There are clinical symptoms of brain dysfunction or severe mental illness and the inability to understand or follow the research protocol;
4. Patients who cannot be guaranteed to complete the necessary treatment plan and follow-up observation;
5. Patients with severe acute allergic reactions;
6. Clinically uncontrolled active infection;
7. Patients who are participating in other clinical trials;
8. Researchers believe that the subject is not suitable for clinical trials for other reasons.
18 Years
60 Years
ALL
No
Sponsors
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Xinqiao Hospital of Chongqing
OTHER
ShiCang Yu
OTHER
Responsible Party
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ShiCang Yu
director of Stem cell and regenerative medicine
Principal Investigators
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Lei Gao
Role: STUDY_CHAIR
Xinqiao Hospital
Locations
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Xinqiao Hospital
Chongqing, Shapingba District, China
Second Affiliated Hospital, Army Medical University, PLA
Chongqing, , China
Countries
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Central Contacts
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Facility Contacts
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Jidong Huang
Role: primary
References
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Kong Y, Song Y, Tang FF, Zhao HY, Chen YH, Han W, Yan CH, Wang Y, Zhang XH, Xu LP, Huang XJ. N-acetyl-L-cysteine improves mesenchymal stem cell function in prolonged isolated thrombocytopenia post-allotransplant. Br J Haematol. 2018 Mar;180(6):863-878. doi: 10.1111/bjh.15119. Epub 2018 Feb 2.
Michalicka M, Boisjoli G, Jahan S, Hovey O, Doxtator E, Abu-Khader A, Pasha R, Pineault N. Human Bone Marrow Mesenchymal Stromal Cell-Derived Osteoblasts Promote the Expansion of Hematopoietic Progenitors Through Beta-Catenin and Notch Signaling Pathways. Stem Cells Dev. 2017 Dec 15;26(24):1735-1748. doi: 10.1089/scd.2017.0133. Epub 2017 Nov 27.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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MSC4PGF
Identifier Type: -
Identifier Source: org_study_id