Not Yet Recruiting

NCT Number: NCT06171906

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

MSC

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xinqiao Hospital, Chongqing, Shapingba District, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mesenchymal Stromal Cells

Biological

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 outcomes

The Hemogram recovery of patients with poor graft function after treatment

Time frame: 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 outcomes

Infection rate

Time frame: 20~40 days after transplantation

Unexpected problems that may occur to the patient or others
graft-versus-host disease

Time frame: 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.
survival rate

Time frame: 1 year after transplantation

1-year overall survival and disease-free survival

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Gao, M.D., Ph.D.

CONTACT

[email protected]

023-68774330

Sponsors and collaborators

Lead sponsor

ShiCang Yu

Other

Collaborators

Xinqiao Hospital of Chongqing

Registry information

Official study title

Clinical Study of MSCs for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2028
First posted: Dec 15, 2023
Registry last updated: Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.