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

Sponsor

Southwest Hospital, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT06149832

Collaborator

Xinqiao Hospital of Chongqing (Other)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Mesenchymal Stem Cells	Biological: Mesenchymal Stem Cells (MSCs)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 30, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Oral cGVHD improves condition [after 2 weeks of treatment]
Oral cGVHD score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

No gender limitation, age <65 years old; KPS score >60, estimated survival >3 months.
No serious damage to the function of major organs of the whole body.
Donor hematopoietic reconstruction was stable (neutrophils >0.5×10^9/L, platelets

20×10^9/L).

Stable control of primary blood diseases.
Voluntary examination, informed consent.

Exclusion Criteria:

Have severe heart, kidney or liver dysfunction.
Those combined with other malignant tumors need treatment.
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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xinqiao Hospital	Shapingba	Chongqing	China

Sponsors and Collaborators

Southwest Hospital, China
Xinqiao Hospital of Chongqing

Investigators

Study Chair: Lei Gao, Xinqiao Hospital, Army Medical University

Study Documents (Full-Text)

Study Protocol - Sep 13, 2023

More Information

Publications

None provided.

Responsible Party:

ShiCang Yu, director of Stem cell and regenerative medicine, Southwest Hospital, China

ClinicalTrials.gov Identifier:

NCT06149832

Other Study ID Numbers:

cGVHD001

First Posted:

Nov 29, 2023

Last Update Posted:

Nov 29, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by ShiCang Yu, director of Stem cell and regenerative medicine, Southwest Hospital, China

Oral Chronic Graft-versus-host Disease

Additional relevant MeSH terms:

Bronchiolitis Obliterans Syndrome

Graft vs Host Disease

Study Results

No Results Posted as of Nov 29, 2023