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.
Participants aged 18 years or older.
Patients who have undergone hematopoietic stem cell transplantation (HSCT).
Patients who have developed mucosal injuries (oral, skin, or bladder) after HSCT, chemotherapy, or radiotherapy.
Patients who are willing to provide informed consent and comply with the study procedures.
Patients with severe organ dysfunction (e.g., heart, liver, kidney failure) that could interfere with the study.
Patients with uncontrolled active infections.
Known allergies or hypersensitivity to MSC supernatant.
Pregnant or breastfeeding women.
Parallel
Standard Care
Other interventionParticipants 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.
MSC Supernatant + Standard Care
Biological/VaccineParticipants 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)
Mucosal Injury Healing
The degree of mucosal injury healing will be assessed using the WHO Mucosal Injury Scale (World Health Organization Mucosal Injury Grading Scale) and a pain score measured by the Visual Analog Scale (VAS) for pain. WHO Mucosal Injury Scale: This scale assesses mucosal injury severity. The grades range from 0 (no injury) to 4 (severe ulceration and bleeding). A lower score indicates better mucosal health. Visual Analog Scale (VAS) for pain: This scale measures pain on a range of 0 (no pain) to 10 (worst pain imaginable). A lower score indicates less pain. The outcome will measure the percentage of participants with WHO mucosal injury grades ≤1 and VAS pain scores ≤2, indicating mild or no injury and low pain.
Mucosal Infection Rates
The number of participants developing secondary infections related to mucosal injuries (oral, skin, bladder) during the study period. This outcome will report infection rates as a percentage of participants.
Hospital Stay Duration
The number of days participants remain hospitalized during the study will be tracked, with comparisons made between the control and intervention groups.
Patient Quality of Life (QoL)
Assessed using the EQ-5D Questionnaire (5 dimensions, scores range from 5 to 25). Lower scores indicate better quality of life. Participants will also rate overall health using the VAS, ranging from 0 (worst) to 100 (best). Higher scores indicate better health. Additionally, participants will rate their overall health using a Visual Analog Scale (VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health), where higher scores indicate better health. Scale: The EQ-5D uses a scale from 1 (no problems) to 5 (extreme problems) for each of the five dimensions. The total score ranges from 5 to 25, with lower scores indicating a better quality of life. Participants will also rate overall health using the VAS, ranging from 0 (worst) to 100 (best). Higher scores indicate better health. EQ-5D: The scale ranges from 1 (no problems) to 5 (extreme problems) across each dimension, with a total score ranging from 5 to 25. Lower scores indicate better quality of life.
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