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

NCT ID: NCT06149832

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2023-11-30

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.

Conditions

Mesenchymal Stem Cells

Keywords

Oral Chronic Graft-versus-host Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MSCs treatment group

Group Type: EXPERIMENTAL

Mesenchymal Stem Cells (MSCs)

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role: collaborator

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

ShiCang Yu

director of Stem cell and regenerative medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lei Gao

Role: STUDY_CHAIR

Army Medical University, China

Locations

Xinqiao Hospital

Shapingba, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lei Gao

Role: CONTACT

Phone: 13228689635

Email: gaolei7765@163.com

Facility Contacts

Lei Gao

Role: primary

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

cGVHD001

Identifier Type: -

Identifier Source: org_study_id