MSCPhase 4NCT06171906
Mesenchymal Stem Cells for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 4 study testing mesenchymal stromal cells in people with MSC, run by ShiCang Yu at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- MSC
- What is being tested?
- mesenchymal stromal cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2024to 1 Nov 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Xinqiao Hospital
Chongqing, Shapingba District, 410000
Jidong Huang, 13228683818, hjdyh@sina.com
Second Affiliated Hospital, Army Medical University, PLA
Chongqing
About this study
Official title: Clinical Study of MSCs 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.
- Conditions
- MSC
- Being tested
- mesenchymal stromal cells
- Keywords
- allo-HSCT, PGF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stromal cellsBiological
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
| Study group | Role | What they receive |
|---|---|---|
| MSCs treatment group | Experimental | Not described Receives: Biological: mesenchymal stromal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hemogram recovery of patients with poor graft function after treatment
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
Measured: 20~40 days after transplantation
Secondary outcomes (3)
Infection rate
Unexpected problems that may occur to the patient or others
Measured: 20~40 days after transplantation
graft-versus-host disease
Graft-versus-host disease (GVHD) is a potentially serious complication of allogeneic stem cell transplantation and reduced-intensity allogeneic stem cell transplantation.
Measured: within the initial 30 to 60 days or further
survival rate
1-year overall survival and disease-free survival
Measured: 1 year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MSCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShiCang Yu
- Sponsor type
- University, hospital or other
- Collaborators
- Xinqiao Hospital of Chongqing
- Responsible party
- Sponsor-investigator, ShiCang Yu, Southwest Hospital, China
- Investigators
- Lei Gao, Study chair, Xinqiao Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171906
- Sponsor's protocol ID
- MSC4PGF
- Status last verified
- Dec 2023
- First submitted
- 6 Nov 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data often contains sensitive information, such as personal details, medical history, or financial records. Protecting the privacy and confidentiality of participants is of utmost importance. Sharing such data without proper safeguards could violate privacy regulations or ethical considerations.
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.
PubMed 29392716Michalicka 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.
PubMed 29050516
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of MSCs for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06171906
- Acronym / sponsor ID
- MSC4PGF
- Conditions
- MSC
- Keywords
- allo-HSCT, PGF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- ShiCang YuUniversity, hospital or other
- Collaborators
- Xinqiao Hospital of Chongqing
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSCs treatment group | Experimental | Biological: mesenchymal stromal cells |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mesenchymal stromal cellsOn 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 | Biological | MSCs treatment group |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Background: PubMed 29392716Kong 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.
- Background: PubMed 29050516Michalicka 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.
- Individual participant dataSharing planned: No. Individual participant data often contains sensitive information, such as personal details, medical history, or financial records. Protecting the privacy and confidentiality of participants is of utmost importance. Sharing such data without proper safeguards could violate privacy regulations or ethical considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Gao study chair
Xinqiao Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mesenchymal stromal cells in people with MSC, run by ShiCang Yu at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Gao, M.D., Ph.D. (023-68774330, gaolei7765@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Hemogram recovery of patients with poor graft function after treatment (time frame: 20~40 days after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06171906, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.