Allogeneic Hematopoietic Stem Cell TransplantationPhase 2/3NCT04247945
Co-transplantation of MSC in the Setting of Allo-HSCT
A Phase 2/3 study testing Cotransplant with MSCs in people with Allogeneic Hematopoietic Stem Cell Transplantation, run by Fujian Medical University at 1 site in China.
Trial summary
Mesenchymal stem cells (MSCs) are known to exhibit immunomodulatory, anti-inflammatory, and pro-angiogenic properties, and therefore have the potential to improve the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) .The study is aimed to identify and evaluate the potential benefits of MSCs… Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation
- What is being tested?
- Cotransplant with MSCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 1 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed written informed consent
- Aged <65 years
- Willing to transplant
- Cardiac: Left ventricular ejection fraction ≥ 50%
- Adequate renal and hepatic function
- Performance status: Karnofsky ≥ 70%
Who cannot join
- Pregnant or lactating females.
- Any co-morbidity precluding the administration of MSCs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital,Fujian Medical University
Fuzhou, Fujian, 350001
Ting Yang, Prof., +86-591-86218041, yang.hopeting@gmail.com
Jianda Hu, Prof., +86-591-86218041, jdhu@medmail.com.cn
About this study
Official title: Co-transplantation of Mesenchymal Stromal Cells in Allogeneic Hematopoietic Stem Cell Transplantation
Mesenchymal stem cells (MSCs) are known to exhibit immunomodulatory, anti-inflammatory, and pro-angiogenic properties, and therefore have the potential to improve the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) .The study is aimed to identify and evaluate the potential benefits of MSCs infusion during allogeneic HSCT, with regard to the engraftment, graft versus host disease (GVHD), post-transplant relapse and survival.
- Being tested
- Cotransplant with MSCs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cotransplant with MSCsBiological
Co-transplantation of MSCs during allogeneic HSCT
| Study group | Role | What they receive |
|---|---|---|
| HSC | No intervention | Not described |
| MSC+HSC | Experimental | Not described Receives: Biological: Cotransplant with MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate
Measured: up to 2 years after HSCT
Secondary outcomes (5)
Cumulative Incidence of Graft-versus Host Disease
Measured: up to 2 years after HSCT
Incidence of Systemic Infections
Measured: up to 2 years after HSCT
Mean Time to Engraftment
Measured: Baseline to engraftment, assessed minimally 28 days post transplant
Transplant-Related Mortality
Measured: up to 1 months after HSCT
Rates of Relapse
Measured: up to 2 years after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting YANG, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247945
- Sponsor's protocol ID
- MSC-SCT-03
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-transplantation of Mesenchymal Stromal Cells in Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04247945
- Acronym / sponsor ID
- MSC-SCT-03
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 30 Jan 2020 (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.
Mesenchymal stem cells (MSCs) are known to exhibit immunomodulatory, anti-inflammatory, and pro-angiogenic properties, and therefore have the potential to improve the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) .The study is aimed to identify and evaluate the potential benefits of MSCs infusion during allogeneic HSCT, with regard to the engraftment, graft versus host disease (GVHD), post-transplant relapse and survival.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSC | No intervention | – |
| MSC+HSC | Experimental | Biological: Cotransplant with MSCs |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Signed written informed consent
- Aged <65 years
- Willing to transplant
- Cardiac: Left ventricular ejection fraction ≥ 50%
- Adequate renal and hepatic function
Key exclusion criteria (2 listed)
- Pregnant or lactating females.
- Any co-morbidity precluding the administration of MSCs.
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 |
|---|---|---|
| Cotransplant with MSCsCo-transplantation of MSCs during allogeneic HSCT | Biological | MSC+HSC |
Primary outcome
Survival Rate
Time frame: up to 2 years after HSCT
5 secondary outcomes
Cumulative Incidence of Graft-versus Host Disease
Time frame: up to 2 years after HSCT
Incidence of Systemic Infections
Time frame: up to 2 years after HSCT
Mean Time to Engraftment
Time frame: Baseline to engraftment, assessed minimally 28 days post transplant
Transplant-Related Mortality
Time frame: up to 1 months after HSCT
Rates of Relapse
Time frame: up to 2 years after HSCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cotransplant with MSCs in people with Allogeneic Hematopoietic Stem Cell Transplantation, run by Fujian Medical University at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Yang, Prof. (+86-591-86218041, yang.hopeting@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Rate (time frame: up to 2 years after HSCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2020.