Actively Recruiting
Study on the Effects of Mesenchymal Stem Cell Culture Supernatant on the Prevention and Treatment of Mucosal Injury in Hematology Patients
Led by The General Hospital of Western Theater Command · Updated on 2024-09-19
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of mesenchymal stem cell (MSC) culture supernatant on preventing and treating mucosal injuries in patients undergoing hematopoietic stem cell transplantation (HSCT). HSCT is a treatment for blood cancers and disorders but often causes severe damage to the mouth lining, skin, and bladder due to high-dose chemotherapy and radiation. This study aims to see if MSC supernatant, which contains healing substances from stem cells, can help repair these injuries and improve recovery without risks related to live cell therapies. Participants will be randomly assigned to two groups: one receives standard care, including oral rinses and pain relief, while the other receives MSC supernatant in addition to standard care. The MSC supernatant will be used as a mouthwash for oral injuries, applied topically for skin injuries, and used for bladder irrigation in bladder injuries. The study will monitor healing progress, safety, and side effects over the course of treatment. During the study, participants will have regular weekly assessments and monthly follow-ups to monitor healing using standardized injury scales and pain scores. Laboratory tests and vital signs will be checked to ensure safety. Researchers will also track infection rates, hospital stay lengths, and quality of life. The trial lasts from October 2020 to September 2025, with 120 patients expected to participate and be followed throughout the study.
CONDITIONS
Brief Title
Effects of Mesenchymal Stem Cell Supernatant on Prevention and Treatment of Skin/Mucosal Injury in Hematology Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
- Patients with HIV or active hepatitis B or C infections.
- Patients who have participated in another clinical trial within the last 4 weeks.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants receive either standard care for mucosal injuries or MSC supernatant in addition to standard care. MSC supernatant is administered based on the type of mucosal injury: as a mouthwash for oral injuries, topically for skin injuries, or bladder irrigation for bladder injuries.
Weekly visits for up to 8 weeks
Duration - Up to 12 weeks
Participants are monitored for safety, infection rates, hospital stay duration, and recovery progress after treatment ends.
Monthly visits for up to 4 months
Trial Site Locations
Total: 1 location
1
Department of Hematology, The General Hospital of Western Theater Command
Chengdu, Sichuan, China, 610083
Actively Recruiting
Research Team
H
Hao Yao, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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