Mesenchymal Stem Cells for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mesenchymal stromal cells.
- Who it may be relevant to
- Registry conditions: MSC. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study of MSCs for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation
Overview
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective approach for treating both benign and malignant blood disorders. It primarily involves high-dose chemotherapy to eliminate tumor cells within the patient's body, as well as to suppress the recipient's hematopoiesis and immune function. The transplantation replaces the recipient's original hematopoietic stem cells (HSCs) with donor-derived HSCs, thereby reconstructing the donor's hematopoietic and immune functions to achieve disease cure. 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.
Interventions
- Biological 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
Primary outcome measures
- The Hemogram recovery of patients with poor graft function after treatment [Time frame: 20~40 days after transplantation]
Secondary outcome measures (3)
- Infection rate [Time frame: 20~40 days after transplantation]
- graft-versus-host disease [Time frame: within the initial 30 to 60 days or further]
- survival rate [Time frame: 1 year after transplantation]
Eligibility criteria
Inclusion criteria
- Screening patients for allogeneic hematopoietic stem cell transplantation;
- No gender limit, age ≥18 years old and ≤60 years old;
- KPS score >60 points, expected survival period >3 months;
- Those without serious functional damage to important organs throughout the body;
- The patient has no other contraindications to hematopoietic stem cell transplantation
- Voluntary test and informed consent.
Exclusion criteria
- Have severe heart, kidney or liver dysfunction;
- Those combined with other malignant tumors need treatment;
- There are clinical symptoms of brain dysfunction or severe mental illness and the inability to understand or follow the research protocol;
- Patients who cannot be guaranteed to complete the necessary treatment plan and follow-up observation;
- Patients with severe acute allergic reactions;
- Clinically uncontrolled active infection;
- Patients who are participating in other clinical trials;
- Researchers believe that the subject is not suitable for clinical trials for other reasons.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Xinqiao Hospital — Chongqing
- Second Affiliated Hospital, Army Medical University, PLA — Chongqing
Publications
- 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. PMID 29392716
- 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. PMID 29050516
Identifiers
NCT: NCT06171906 · MSC4PGF