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

NCT06149832 | Unknown Phase 4

• 1 other identifier: cGVHD001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Oral cGVHD improves condition

  Oral cGVHD score

  after 2 weeks of treatment

Study Arms (1)

MSCs treatment group

EXPERIMENTAL

Biological: Mesenchymal Stem Cells (MSCs)

Interventions

Mesenchymal Stem Cells (MSCs) 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.

MSCs treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southwest Hospital, China: lead
• Xinqiao Hospital of Chongqing: collaborator

Study Sites (1)

Xinqiao Hospital

Shapingba, Chongqing Municipality, China

RECRUITING

Study Officials

• Lei Gao

  Army Medical University, China

  STUDY CHAIR

Central Study Contacts

Lei Gao

CONTACT

13228689635; gaolei7765@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Stem cell and regenerative medicine

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 29, 2023
• Study Start: November 30, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)