Treatment for oral chronic graft-versus-host disease using stem cells

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

This study is testing if a new treatment using stem cells from umbilical cords can help people with oral chronic graft-versus-host disease feel better and improve their quality of life.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Southwest Hospital, China (Academic / other)
• Locations: 1 site (Shapingba, Chongqing)
• Trial ID: NCT06149832 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of human umbilical cord mesenchymal stem cell dressing in treating oral chronic graft-versus-host disease (cGVHD), a condition where donor immune cells attack the recipient's oral tissues following stem cell transplantation. The study focuses on providing a local treatment option that is simple, effective, and has low toxicity, addressing the limitations of current systemic treatments and local therapies. Participants will be monitored for improvements in symptoms such as oral ulcers and pain, with the goal of enhancing their quality of life.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals under 65 years old with stable donor hematopoietic reconstruction and no severe organ dysfunction.

Not a fit: Patients with severe heart, kidney, or liver dysfunction, or those with uncontrolled active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from oral chronic graft-versus-host disease.

How similar studies have performed: While there is ongoing research into the use of mesenchymal stem cells for various conditions, this specific approach for oral cGVHD is relatively novel and has not been extensively tested.

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.

Where this trial is running

Shapingba, Chongqing

• Xinqiao Hospital — Shapingba, Chongqing, China (Recruiting)

Study contacts

• Study coordinator: Lei Gao

Conditions Mesenchymal Stem Cells; Oral Chronic Graft-versus-host Disease