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Chronic Graft-versus-host DiseasePhase 2NCT04692376

MSC for Treatment of cGVHD After Allo-HSCT

A Phase 2 study testing Mesenchymal stem cells, Glucocorticoids and cyclosporine in people with Chronic Graft-versus-host Disease, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of mesenchymal stem cells in patients with chronic graft-versus-host disease. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Graft-versus-host Disease
What is being tested?
Mesenchymal stem cells, Glucocorticoids and cyclosporine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteChina
Study dates
10 Jan 2021to 30 Jun 2023
Phase
Phase 2
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A patient age of 18-65 years
  • Recipients of allogeneic hematopoietic stem cell transplantation Patients with moderate/ severe cGVHD without systemic treatment
  • Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Who cannot join

  • Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
  • Primary disease relapse
  • Expected lifetime less than 3 months
  • Patients with any conditions not suitable for the trial (investigators' decision)

Trial locations and contacts

1 site in 1 country.

Ren Lin, MD contact

+86-020-62787883

lansinglinren@hotmail.com

China1 site, 1 recruiting

  • Department of Hematology,Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

    Ren Lin, MD, +86-020-61641613, lansinglinren@hotmail.com

    Qifa Liu

    Recruiting

Other trials in China

About this study

Official title: Mesenchymal Stem Cell for Treatment of Chronic Graft-versus-host Disease After Allogenetic Hematopoietic Stem Cell Transplantation

The purpose of this study is to evaluate the efficacy of mesenchymal stem cells in patients with chronic graft-versus-host disease.

Read the detailed description

Allogeneic hematopoietic stem cell transplantation(allo-HSCT) can cure many hematologic diseases. Although great progress has been made in the prevention and treatment of side effects associated with transplantation,chronic graft-versus-host disease(cGVHD) remains an important complication that occurs in about 50% patients. The mortality of cGVHD and its complication could reach up to 50%,and cGVHD seriously influence the quality of life. At present, the first line treatment of cGVHD remains in discussion.

Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating GVHD after allo-HSCT and so on. However, the efficacy of treatment of cGVHD remains undetermined.

In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded MSCs in treating patients with cGVHD.

Being tested
Mesenchymal stem cells, Glucocorticoids, cyclosporine
Keywords
Hematopoietic Stem Cell Transplantation, Chronic Graft-versus-host disease, Mesenchymal Stem Cells
Medical subject headings
Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenchymal stem cellsBiological

    Mesenchymal stem cells (MSCs) will be intravenously infused via a central venous catheter(at a dose of 1×10^6 cells/kg, over 15 mins) weekly. MSCs will be administrated for 8 doses.

  • GlucocorticoidsDrug

    Glucocorticoids (i.e. Methylprednisolone) will be used with an initial dose of 1mg/kg.

  • cyclosporineDrug

    Cyclosporine (CsA) will be used with an initial dose of 2.5mg/kg/d and adjusted according to the concentration of CsA. The targeted concentration is 200-300 ng/Ml.

Study groups in NCT04692376
Study groupRoleWhat they receive
MSCs groupExperimentalMSCs group refers to treatment with mesenchymal stem cells (1×10^6 cells/kg, intravenously) weekly for 8 doses. Besides, glucocorticoids and cyclosporine (CsA) will be used for treatment concurrently.
Receives: Biological: Mesenchymal stem cells; Drug: Glucocorticoids; Drug: cyclosporine
Control groupActive comparatorGlucocorticoids and CsA will be used for treatment.
Receives: Drug: Glucocorticoids; Drug: cyclosporine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Overall response rate （ORR）includes complete response (CR) and part response (PR).

    Measured: 12 weeks after the first dose of MSCs

Secondary outcomes (6)

  1. OS

    Overall survival (OS)

    Measured: 1 year after the first dose of MSCs

  2. DFS

    Disease-free survival (DFS)

    Measured: 1 year after the first dose of MSCs

  3. Response rate

    Measured: 4 weeks after the first dose of MSCs

  4. EBV DNA-emia

    EBV DNA-emia refers to detection of EBV DNA in peripheral blood via PCR.

    Measured: 1 year after the first dose of MSCs

  5. CMV DNA-emia

    CMV DNA-emia refers to detection of CMV DNA in peripheral blood via PCR.

    Measured: 1 year after the first dose of MSCs

  6. PGF

    Poor graft function (PGF) refers to a slow or incomplete recovery of blood cell counts (ANC ≤0.5x10^9/L and PLT ≤20x10^9/L) by +28 days after allo-HSCT or a fall in blood cell counts to levels fulfilling the diagnostic criteria for PGF after successful and prompt hematopoietic engraftment.

    Measured: 1 year after the first dose of MSCs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2020
  2. Study start10 Jan 2021 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04692376
Sponsor's protocol ID
MSC-cGVHD-2020
Status last verified
Dec 2020
First submitted
26 Dec 2020
Last updated
31 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mesenchymal stem cells, Glucocorticoids and cyclosporine in people with Chronic Graft-versus-host Disease, run by Nanfang Hospital, Southern 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 3 inclusion and 4 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 31 Dec 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 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.

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 Ren Lin, MD (+86-020-62787883, lansinglinren@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 12 weeks after the first dose of MSCs). 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 NCT04692376.

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 31 Dec 2020.

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