Treatment of Oral Chronic Graft-versus-host Disease With Human Umbilical Cord Mesenchymal Stem Cell Dressing

Chronic graft-versus-host disease (cGVHD) is a clinicopathological syndrome caused by donor lymphocytes attacking the recipient's organs during the process of reestablishing donor immunity after allogeneic hematopoietic stem cell transplantation (allo-HSCT), with an incidence of about 30%-70%. The clinical manifestations of cGVHD are varied, the course of the disease is prolonged, and the quality of life of patients is affected, and the long-term survival is affected. Among them, oral cGVHD is the most common type, which mainly presents with lichen planus, oral ulcers, mucosal atrophy, erythema and pain. At present, the treatment of oral cGVHD is based on systemic treatment and local hormone-containing gargling solution and local photochemotherapy. The former is easy to be complicated by oral local fungal infection, while the latter has no such equipment in China. Therefore, it is urgent to establish a simple, effective and low-toxicity local treatment for oral cGVHD. Mesenchymal stem cells (MSCs) are one of the most widely used cell products in clinic. The combination of MSCS and hematopoietic stem cells can improve the success rate of transplantation and accelerate hematopoietic reconstruction. The applicant team previously completed a national multi-center clinical study on MSCs prevention of cGVHD, which proved that sequential infusion of MSCs can effectively reduce the incidence of cGVHD, and the mechanism is that MSCs regulate Th1: Th2 balance and promote the differentiation of T cells to Th1 direction. Our previous mechanism study provides an important theoretical basis for MSCs treatment of oral cGVHD. According to the clinical needs and the rich experience of our research group in the field of MSCs clinical research, we plan to use dressing containing MSCs for the local treatment of oral cGVHD, so as to improve the lesion degree of oral cGVHD and improve the quality of life of allo-HSCT patients, and provide clinical experience for reference for the local treatment of MSCs graft-versus-host disease.

Study Overview

• Status: Recruiting
• Conditions: Mesenchymal Stem Cells
• Intervention / Treatment: Biological: Mesenchymal Stem Cells (MSCs)

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lei Gao; Phone Number: 13228689635; Email: gaolei7765@163.com

Study Locations

• China
  • Chongqing
    • Shapingba, Chongqing, China
      • Recruiting
      • Xinqiao Hospital
      • Contact: Lei Gao; Phone Number: 13228689635; Email: gaolei7765@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. No gender limitation, age <65 years old; KPS score >60, estimated survival >3 months.
2. No serious damage to the function of major organs of the whole body.
3. Donor hematopoietic reconstruction was stable (neutrophils >0.5×10^9/L, platelets >20×10^9/L).
4. Stable control of primary blood diseases.
5. Voluntary examination, informed consent.

Exclusion Criteria:

1. Have severe heart, kidney or liver dysfunction.
2. Those combined with other malignant tumors need treatment.
3. There are clinical symptoms of brain dysfunction or severe mental illness and the inability to understand or follow the research protocot4. Patients who cannot be guaranteed to complete the necessary treatment plan and follow-up observation.

5. Patients with severe acute allergic reactions. 6. Clinically uncontrolled active infection. 7. Patients who are participating in other clinical trials. 8. Researchers believe that the subject is not suitable for clinical trials for other reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MSCs treatment group	Biological: Mesenchymal Stem Cells (MSCs); The patient's mouth (including buccal mucosa, tongue and lip) was applied with MSCs: MSCs (1×10^6/ml) dressing was applied 4 times/day for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral cGVHD improves condition	Oral cGVHD score	after 2 weeks of treatment

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Collaborators: Xinqiao Hospital of Chongqing
• Investigators: Study Chair: Lei Gao, Xinqiao Hospital, Army Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 24, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Oral Chronic Graft-versus-host Disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis Obliterans; Bronchiolitis; Organizing Pneumonia; Graft vs Host Disease; Bronchiolitis Obliterans Syndrome
• Other Study ID Numbers: cGVHD001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No