Graft vs Host DiseasePhase 1NCT07826676
Use of Bone Marrow Stem Cells (MesenCell) for the Treatment of Patients With Chronic Graft-versus-host Disease
A Phase 1 study testing Mesenchymal Stem Cell Infusion in people with Graft vs Host Disease and Mesenchymal Stem Cell Transplantation, run by Pontifícia Universidade Católica do Paraná at 4 sites in Brazil.
Trial summary
The purpose of this Phase I clinical trial is to evaluate the safety and potential treatment response of bone marrow-derived mesenchymal stem cells (MesenCell) in adult patients with moderate or severe chronic graft-versus-host disease (cGVHD) that is refractory to corticosteroid treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Graft vs Host Disease, Mesenchymal Stem Cell Transplantation
- What is being tested?
- Mesenchymal Stem Cell Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesBrazil
- Study dates
- Oct 2026to Oct 2028
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 70 years;
- Male or female sex;
- Patients after allogeneic hematopoietic stem cell transplantation (any donor or stem cell source);
- Presenting with moderate or severe chronic Graft versus host Disease refractory to treatment with corticosteroids and calcineurin inhibitors;
- Patients who agree to participate in this study and who sign the Informed Consent Form.
Who cannot join
- Patients with any concomitant clinical condition that, in the physician's opinion, contraindicates the infusion of bone marrow-containing stem cells;
- Pregnancy;
- Patients (or their legal guardians) who do not agree to participate in this study or who do not sign the Informed Consent Form;
- Patients with recurrent malignant neoplasm.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil4 sites
Hospital de Clínicas da Universidade Federal do Paraná
Curitiba, Paraná, 80060-150
Vaneuza M Funke, 5541999627985, vfunke@gmail.com
Pontifícia Universidade Católica do Paraná
Curitiba, Paraná, 80215200
Carmen L K Rebelatto, +554132711858 ext. 1858, carmen.rebelatto@pucpr.br
Carmen LK Rebelatto
Hospital Nossa Senhora das Graças
Curitiba, Paraná, 80810040
Vaneuza A M Funke, 4199277235, gahe.pesquisaclinica@gmail.com
Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060
João S H Farias, 4199846033, jshfarias@gmail.com
About this study
Official title: Use of Bone Marrow-Derived Mesenchymal Stem Cells (Mesencell) for the Treatment of Patients Undergoing Hematopoietic Progenitor Cell Transplantation Who Developed Refractory Moderate or Severe Chronic Graft-versus-Host Disease: A Phase I Clinical Trial
The purpose of this Phase I clinical trial is to evaluate the safety and potential treatment response of bone marrow-derived mesenchymal stem cells (MesenCell) in adult patients with moderate or severe chronic graft-versus-host disease (cGVHD) that is refractory to corticosteroid treatment. The main questions it seeks to answer are:
- Is MesenCell infusion safe in patients with corticosteroid-refractory chronic graft-versus-host disease?
- Can MesenCell treatment improve the clinical response and disease control in these patients?
Participants will receive one to three intravenous infusions of MesenCell, according to the study protocol and be followed for 12 months after the last MesenCell infusion.
Read the detailed description
This is a prospective, single-arm, open-label Phase I clinical trial designed to evaluate the safety and treatment response of bone marrow-derived mesenchymal stem cells (MesenCell) in adult patients with moderate or severe chronic graft-versus-host disease (cGVHD) refractory to corticosteroid treatment.
Approximately 20 participants will be enrolled in the study. Participants will receive one to three intravenous infusions of MesenCell at a dose of 2 × 10⁶ cells/kg, administered at seven-day intervals. The number of infusions will depend on the dose-escalation level to which each participant is assigned.
MesenCell will be administered in combination with standard treatment consisting of corticosteroids at a dose of 1 mg/kg/day and cyclosporine. Participants will undergo clinical and laboratory monitoring throughout the study to evaluate the safety of the intervention and the occurrence, frequency, severity, and causal relationship of adverse events following MesenCell infusion.
Treatment response will be assessed using standardized criteria for chronic graft-versus-host disease, including overall and organ-specific response. The study will also evaluate all-cause mortality, failure-free survival, and changes in corticosteroid and immunosuppressive medication use, including dose reductions, treatment discontinuation, and reduction in the number of immunosuppressive agents.
Participants will be followed for 12 months after administration of the last MesenCell dose. During this period, clinical assessments and review of medical records will be performed to monitor treatment response, disease progression, safety outcomes, need for additional systemic therapy, mortality, and changes in concomitant immunosuppressive treatment.
- Being tested
- Mesenchymal Stem Cell Infusion
- Keywords
- Advanced Therapy Medicinal Products, Security, Adverse events
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cell InfusionBiological
Also called Mesenchymal Stem Cell Transplantation
Administration of Advanced Therapy Medicinal Product in patients with chronic GVHD
| Study group | Role | What they receive |
|---|---|---|
| MesenCell | Experimental | Patient will receive 1 to 3 intravenous infusions of 2 × 10⁶/kg of Mesenchymal stem cells (MSCs) at 7 day intervals Receives: Biological: Mesenchymal Stem Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events
Number of participants experiencing unexpected adverse events or adverse events considered probably or definitely attributable to MesenCell infusion within 30 days after the last dose. Adverse events will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 (2025). Grade 3 or higher events will be considered for toxicity assessment.
Measured: 30 days after the last MesenCell infusion
Secondary outcomes (8)
Overall Treatment Response Rate
Percentage of participants with partial or complete overall response, according to the 2014 National Institutes of Health (NIH) Consensus Development Project response criteria for chronic graft-versus-host disease.
Measured: 6 months after treatment initiation
Change in Overall Response
Change from baseline in overall severity according to the 2014 National Institutes of Health (NIH) Consensus Development Project criteria. Overall severity is classified as mild, moderate, or severe based on the number of organs involved and the severity scores assigned to each affected organ. Mild disease is defined as involvement of 1 or 2 organs, with no organ scoring more than 1, and a lung score of 0. Moderate disease is defined as involvement of 3 or more organs with no organ scoring more than 1, or at least 1 non-lung organ with a score of 2, or a lung score of 1. Severe disease is defined as at least 1 organ with a score of 3 or a lung score of 2 or 3.
Measured: From baseline through 12 months after treatment initiation
Change in Organ-Specific Response Scores
Change from baseline in organ-specific response scores for the skin, mouth, eyes, gastrointestinal tract, liver, lungs, joints and fascia, and genital tract. Each organ is scored on an ordinal scale from 0 to 3 according to predefined clinical or laboratory criteria specific to the affected organ. A score of 0 indicates no signs or symptoms, while a score of 3 indicates severe involvement. Higher scores indicate greater disease severity and a worse outcome.
Measured: From baseline through 12 months after treatment initiation
All-cause mortality
Time from the first MesenCell infusion to death from any cause. Survival will be estimated at 6 and 12 months and as median overall survival during the follow-up period. Participants who remain alive will be censored at the last contact.
Measured: From the first MesenCell infusion through 12 months after the last MesenCell infusion
Failure-Free Survival
Time from the first MesenCell infusion to the first occurrence of treatment failure, defined as relapse of the underlying disease, progression or reactivation of chronic graft-versus-host disease, or death from any cause. Relapse of the underlying disease will be assessed primarily by complete blood count, with bone marrow aspirate performed when relapse is suspected based on blood count findings. Reactivation of chronic graft-versus-host disease will be assessed at each medical visit according to the NIH organ scoring criteria. Participants without treatment failure will be censored at the last contact. Failure-free survival will be estimated at 6 and 12 months.
Measured: From the first MesenCell infusion through 12 months after the last MesenCell infusion
Reduction in Corticosteroid Therapy
Percentage of participants who have a reduction in corticosteroid dose compared with baseline during the follow-up period. Corticosteroid dose will be assessed using medical records, prescription data, and clinical follow-up.
Measured: From treatment initiation through 12 months after the last MesenCell infusion
Discontinuation of Immunosuppressive Therapy
Percentage of participants who discontinue systemic immunosuppressive therapy during the follow-up period. Immunosuppressive therapy use and discontinuation will be determined from medical records, prescription data, and clinical follow-up.
Measured: From treatment initiation through 12 months after the last MesenCell infusion
Time to Best Overall Response
Time from the first MesenCell infusion to the first documentation of the best overall response according to the 2014 National Institutes of Health (NIH) Consensus Development Project response criteria for chronic graft-versus-host disease.
Measured: From the first MesenCell infusion through 12 months after the last MesenCell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft vs Host DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm, open-label, phase I clinical study. Twenty patients with chronic corticosteroid-refractory graft-versus-host disease will receive 1 to 3 intravenous infusions of 2 × 10⁶/kg at 7 day intervals-the number of infusions will depend on the escalation level to which the participant was allocated. Patient follow-up will be at 12 months after the last dose of MesenCell. The infusion will be performed in conjunction with standard treatment with corticosteroids (1 mg/kg of body weight per day) and cyclosporine.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontifícia Universidade Católica do Paraná
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Erasto Gaertner, Hospital de Clínicas da Universidade Federal do Paraná, Brazil, Hospital Nossa Senhora das Graças, Financiadora de Estudos e Projetos
- Responsible party
- Principal investigator, Carmen Rebelatto, Pontifícia Universidade Católica do Paraná
- Investigators
- Carmen L K Rebelatto, PhD, Principal investigator, Pontifícia Universidade Católica do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826676
- Sponsor's protocol ID
- DECH_PhaseI
- Other IDs
- 93991925.9.1001.0020, RBR-22jd7g5, U1111-1295-1917
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SJ, Wolff D, Kitko C, Koreth J, Inamoto Y, Jagasia M, Pidala J, Olivieri A, Martin PJ, Przepiorka D, Pusic I, Dignan F, Mitchell SA, Lawitschka A, Jacobsohn D, Hall AM, Flowers ME, Schultz KR, Vogelsang G, Pavletic S. Measuring therapeutic response in chronic graft-versus-host disease. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: IV. The 2014 Response Criteria Working Group report. Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99. doi: 10.1016/j.bbmt.2015.02.025. Epub 2015 Mar 19.
PubMed 25796139
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Bone Marrow-Derived Mesenchymal Stem Cells (Mesencell) for the Treatment of Patients Undergoing Hematopoietic Progenitor Cell Transplantation Who Developed Refractory Moderate or Severe Chronic Graft-versus-Host Disease: A Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT07826676
- Acronym / sponsor ID
- DECH_PhaseI
- Keywords
- Advanced Therapy Medicinal Products, Security, Adverse events
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pontifícia Universidade Católica do ParanáUniversity, hospital or other
- Collaborators
- Hospital Erasto Gaertner, Hospital de Clínicas da Universidade Federal do Paraná, Brazil, Hospital Nossa Senhora das Graças, Financiadora de Estudos e Projetos
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 17 Sep 2026 (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.
The purpose of this Phase I clinical trial is to evaluate the safety and potential treatment response of bone marrow-derived mesenchymal stem cells (MesenCell) in adult patients with moderate or severe chronic graft-versus-host disease (cGVHD) that is refractory to corticosteroid treatment. The main questions it seeks to answer are:
- Is MesenCell infusion safe in patients with corticosteroid-refractory chronic graft-versus-host disease?
- Can MesenCell treatment improve the clinical response and disease control in these patients?
Participants will receive one to three intravenous infusions of MesenCell, according to the study protocol and be followed for 12 months after the last MesenCell infusion.
Detailed description
This is a prospective, single-arm, open-label Phase I clinical trial designed to evaluate the safety and treatment response of bone marrow-derived mesenchymal stem cells (MesenCell) in adult patients with moderate or severe chronic graft-versus-host disease (cGVHD) refractory to corticosteroid treatment.
Approximately 20 participants will be enrolled in the study. Participants will receive one to three intravenous infusions of MesenCell at a dose of 2 × 10⁶ cells/kg, administered at seven-day intervals. The number of infusions will depend on the dose-escalation level to which each participant is assigned.
MesenCell will be administered in combination with standard treatment consisting of corticosteroids at a dose of 1 mg/kg/day and cyclosporine. Participants will undergo clinical and laboratory monitoring throughout the study to evaluate the safety of the intervention and the occurrence, frequency, severity, and causal relationship of adverse events following MesenCell infusion.
Treatment response will be assessed using standardized criteria for chronic graft-versus-host disease, including overall and organ-specific response. The study will also evaluate all-cause mortality, failure-free survival, and changes in corticosteroid and immunosuppressive medication use, including dose reductions, treatment discontinuation, and reduction in the number of immunosuppressive agents.
Participants will be followed for 12 months after administration of the last MesenCell dose. During this period, clinical assessments and review of medical records will be performed to monitor treatment response, disease progression, safety outcomes, need for additional systemic therapy, mortality, and changes in concomitant immunosuppressive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm, open-label, phase I clinical study. Twenty patients with chronic corticosteroid-refractory graft-versus-host disease will receive 1 to 3 intravenous infusions of 2 × 10⁶/kg at 7 day intervals-the number of infusions will depend on the escalation level to which the participant was allocated. Patient follow-up will be at 12 months after the last dose of MesenCell. The infusion will be performed in conjunction with standard treatment with corticosteroids (1 mg/kg of body weight per day) and cyclosporine.
| Arm | Type | Receives |
|---|---|---|
| MesenCell | Experimental | Biological: Mesenchymal Stem Cell InfusionPatient will receive 1 to 3 intravenous infusions of 2 × 10⁶/kg of Mesenchymal stem cells (MSCs) at 7 day intervals |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age from 18 to 70 years;
- Male or female sex;
- Patients after allogeneic hematopoietic stem cell transplantation (any donor or stem cell source);
- Presenting with moderate or severe chronic Graft versus host Disease refractory to treatment with corticosteroids and calcineurin inhibitors;
- Patients who agree to participate in this study and who sign the Informed Consent Form.
Key exclusion criteria (4 listed)
- Patients with any concomitant clinical condition that, in the physician's opinion, contraindicates the infusion of bone marrow-containing stem cells;
- Pregnancy;
- Patients (or their legal guardians) who do not agree to participate in this study or who do not sign the Informed Consent Form;
- Patients with recurrent malignant neoplasm.
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 Stem Cell InfusionAlso: Mesenchymal Stem Cell TransplantationAdministration of Advanced Therapy Medicinal Product in patients with chronic GVHD | Biological | MesenCell |
Primary outcome
Number of Participants With Treatment-Related Adverse Events
Time frame: 30 days after the last MesenCell infusion
Number of participants experiencing unexpected adverse events or adverse events considered probably or definitely attributable to MesenCell infusion within 30 days after the last dose. Adverse events will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 (2025). Grade 3 or higher events will be considered for toxicity assessment.
8 secondary outcomes
Overall Treatment Response Rate
Time frame: 6 months after treatment initiation
Change in Overall Response
Time frame: From baseline through 12 months after treatment initiation
Change in Organ-Specific Response Scores
Time frame: From baseline through 12 months after treatment initiation
All-cause mortality
Time frame: From the first MesenCell infusion through 12 months after the last MesenCell infusion
Failure-Free Survival
Time frame: From the first MesenCell infusion through 12 months after the last MesenCell infusion
Reduction in Corticosteroid Therapy
Time frame: From treatment initiation through 12 months after the last MesenCell infusion
Discontinuation of Immunosuppressive Therapy
Time frame: From treatment initiation through 12 months after the last MesenCell infusion
Time to Best Overall Response
Time frame: From the first MesenCell infusion through 12 months after the last MesenCell infusion
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 17 Sep 2026.
- Background: PubMed 25796139Lee SJ, Wolff D, Kitko C, Koreth J, Inamoto Y, Jagasia M, Pidala J, Olivieri A, Martin PJ, Przepiorka D, Pusic I, Dignan F, Mitchell SA, Lawitschka A, Jacobsohn D, Hall AM, Flowers ME, Schultz KR, Vogelsang G, Pavletic S. Measuring therapeutic response in chronic graft-versus-host disease. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: IV. The 2014 Response Criteria Working Group report. Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99. doi: 10.1016/j.bbmt.2015.02.025. Epub 2015 Mar 19.
- Individual participant dataSharing planned: No
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Graft vs Host Disease
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.
Carmen L K Rebelatto, PhD principal investigator
Pontifícia Universidade Católica do Paraná
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal Stem Cell Infusion in people with Graft vs Host Disease and Mesenchymal Stem Cell Transplantation, run by Pontifícia Universidade Católica do Paraná at 4 sites in Brazil.
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 5 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Carmen L K Rebelatto, PhD (+554132711858 ext. 1858, carmen.rebelatto@pucpr.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events (time frame: 30 days after the last MesenCell infusion). 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 NCT07826676, which also lists 1 linked publication.
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 17 Sep 2026.