Use of Bone Marrow Stem Cells (MesenCell) for the Treatment of Patients With Chronic Graft-versus-host Disease

NCT07826676 | Not Yet Recruiting Phase 1 DMC

• 4 other identifiers: DECH_PhaseI93991925.9.1001.0020RBR-22jd7g5U1111-1295-1917
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Mesenchymal Stem Cell Transplantation; Graft vs Host Disease

Keywords

Advanced Therapy Medicinal Products; Security; Adverse events

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days after the last MesenCell infusion

Secondary Outcomes (8)

• Overall Treatment Response Rate

  6 months after treatment initiation

• Change in Overall Response

  From baseline through 12 months after treatment initiation

• Change in Organ-Specific Response Scores

  From baseline through 12 months after treatment initiation

• All-cause mortality

  From the first MesenCell infusion through 12 months after the last MesenCell infusion

• Failure-Free Survival

  From the first MesenCell infusion through 12 months after the last MesenCell infusion

Study Arms (1)

MesenCell

EXPERIMENTAL

Patient will receive 1 to 3 intravenous infusions of 2 × 10⁶/kg of Mesenchymal stem cells (MSCs) at 7 day intervals

Biological: Mesenchymal Stem Cell Infusion

Interventions

Mesenchymal Stem Cell Infusion BIOLOGICAL

Administration of Advanced Therapy Medicinal Product in patients with chronic GVHD

Also known as: Mesenchymal Stem Cell Transplantation

MesenCell

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontifícia Universidade Católica do Paraná: lead
• Hospital Erasto Gaertner: collaborator
• Hospital de Clínicas da Universidade Federal do Paraná, Brazil: collaborator
• Hospital Nossa Senhora das Graças: collaborator
• Financiadora de Estudos e Projetos: collaborator

Study Sites (4)

Hospital de Clínicas da Universidade Federal do Paraná

Curitiba, Paraná, 80060-150, Brazil

Location

Pontifícia Universidade Católica do Paraná

Curitiba, Paraná, 80215200, Brazil

Location

Hospital Nossa Senhora das Graças

Curitiba, Paraná, 80810040, Brazil

Location

Hospital Erasto Gaertner

Curitiba, Paraná, 81520-060, Brazil

Location

Related Publications (1)

• 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.

  PMID: 25796139 BACKGROUND

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Mesenchymal Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Carmen L K Rebelatto, PhD

  Pontifícia Universidade Católica do Paraná

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen L K Rebelatto, PhD

CONTACT

+554132711858; carmen.rebelatto@pucpr.br

Lidiane M. B. Leite, PhD

CONTACT

+554132711858; lidiane.leite@pucpr.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (4)