Mesenchymal Stem Cells for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation

Phase 4

Not yet recruiting

• Conditions: MSC
• Interventions: Biological: mesenchymal stromal cells

• Registration Number: NCT06171906
• Lead Sponsor: ShiCang Yu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-06
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-15
• Last Update Posted: 2023-12-15
• Study Start: 2024-01-01
• Primary Completion: 2025-10-01
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Screening patients for allogeneic hematopoietic stem cell transplantation;
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

1. Have severe heart, kidney or liver dysfunction;
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MSCs treatment group	mesenchymal stromal cells	-

Primary Outcome Measures

Name	Time	Method
The Hemogram recovery of patients with poor graft function after treatment	20~40 days after transplantation	White blood cells: neutrophil engraftment is defined as neutrophils exceeding 0.5×10\^9/L for 3 consecutive days; red blood cells: hemoglobin is not less than 70g/L, and is free of blood transfusion; Platelets: Complete response is defined as platelet count ≥50×10\^9/L, continuous for 7 days without platelet transfusion; Partial response (PR) is defined as platelet count (20\~50)×10\^9/L, continuous Weaning from platelet transfusion at 7 days; no response (NR) is defined as 8 weeks of use at the maximum tolerated dose, platelet count \<20×10\^9/L or not weaning from platelet transfusion

Secondary Outcome Measures

Name	Time	Method
survival rate	1 year after transplantation	1-year overall survival and disease-free survival
Infection rate	20~40 days after transplantation	Unexpected problems that may occur to the patient or others
graft-versus-host disease	within the initial 30 to 60 days or further	Graft-versus-host disease (GVHD) is a potentially serious complication of allogeneic stem cell transplantation and reduced-intensity allogeneic stem cell transplantation.

Trial Locations

Locations (2)

Second Affiliated Hospital, Army Medical University, PLA; 🇨🇳 Chongqing, China

Xinqiao Hospital; 🇨🇳 Chongqing, Shapingba District, China