Effects of Mesenchymal Stem Cell Supernatant on Prevention and Treatment of Skin/Mucosal Injury in Hematology Patients

Summary

This clinical trial is studying the effects of mesenchymal stem cell (MSC) culture supernatant on the prevention and treatment of mucosal injuries in patients undergoing hematopoietic stem cell transplantation (HSCT). HSCT is a common treatment for blood-related cancers and other serious blood disorders. However, many patients experience severe damage to their mucous membranes, including the lining of the mouth, skin, and bladder, due to the high-dose chemotherapy used in the treatment process. These mucosal injuries can cause pain, increase the risk of infection, and lower the patient's quality of life.

The purpose of this study is to determine whether MSC culture supernatant can help repair mucosal injuries and improve recovery for these patients. MSC culture supernatant contains substances produced by mesenchymal stem cells that may promote healing and reduce inflammation. These substances could potentially repair tissue without the risks associated with using live cells.

Participants in this trial will be randomly assigned to one of two groups: one group will receive standard care, and the other will receive MSC culture supernatant as part of their treatment. The study will look at how well MSC supernatant helps heal mucosal injuries, as well as its safety and any side effects that may occur. The outcomes of this study could lead to new ways to prevent and treat mucosal injuries in patients undergoing HSCT, improving their quality of life during and after treatment.

The trial will include 120 patients who have undergone HSCT and experienced mucosal injuries. The study will last approximately five years, from October 2020 to September 2025. Participants will be monitored throughout the trial for safety and effectiveness of the treatment, with follow-up visits scheduled to assess their progress.

Conditions

• Mucositis
• Hematopoietic Stem Cell Transplantation
• Chemotherapy-Induced Mucositis
• Radiation-Induced Mucositis

Interventions

OTHER

Standard Care

Participants in this arm will receive standard care for mucosal injuries, which may include oral rinses, topical treatments, and supportive care based on the type of injury.

BIOLOGICAL

MSC Supernatant + Standard Care

Participants in this arm will receive MSC supernatant in addition to standard care. MSC supernatant will be administered as follows: 15 mL for oral mucosal injuries (mouthwash) Topical application for skin mucosal injuries (based on body surface area) 50 mL for bladder injuries (bladder irrigation)

Sponsors & Collaborators

• The General Hospital of Western Theater Command

  lead OTHER

Principal Investigators

• Dan Chen, Bachelor · Department of Hematology, The General Hospital of Western Theater Command

• Hao Yao, Ph.D · Department of Hematology, The General Hospital of Western Theater Command

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-01

Primary Completion

2025-09-30

Completion

2025-09-30

Countries

• China

Study Locations