Radiation-induced Skin damage
Conditions
Interventions
treatment group:Human placenta MSCs gel was used for treatment. Apply locally, use 1 tube (1 ×10 ^6 cells/tube) on a 15cm^2 wound, adjust the dosage according to the wound area, once a day, for 6 cons
Control group:Blank gel was used for treatment. Apply locally, use 1 tube on a 15cm^2 wound, adjust the dosage according to the wound area, once a day, for 6 consecutive times (researchers may extend
Sponsors
Yunnan Cancer Hospital / The Third Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 70 years old 2) Subjects undergoing tumor radiotherapy at Yunnan Cancer Hospital 3) Subjects who meet the grading criteria for radiation-induced skin injury (using the RTOG acute radiation-induced skin injury grading criteria and RTOG/ORTC late stage radiation-induced skin injury grading criteria of the United States Cancer Radiotherapy Collaboration Group) with a grade of II or above (tender or bright erythema, patchy wet peeling/moderate edema) 4) Skin injury wound with a length diameter greater than 2cm 5) ECOG score 0-1, expected survival period greater than six months 6) Peripheral blood count, liver, kidney, and coagulation function will be determined by the researcher to determine whether they meet the inclusion requirements 7) Subjects without intellectual or mental disorders, with normal language expression ability, able to judge their own pain and general conditions, and able to cooperate in evaluating pain and quality of life content 8) Participants who have given informed consent to participate in this study and signed the informed consent form, have good compliance, and are eligible for follow-up
Exclusion criteria
Exclusion criteria: 1) Clearly identify subjects with skin injuries caused by non radioactive factors 2) Merge other skin diseases that may affect clinical evaluation, including infectious dermatitis 3) Subjects with active tuberculosis and other serious infectious diseases 4) Subjects with severe cardiovascular, cerebrovascular, liver, kidney, hematopoietic system and other diseases 5) Subjects allergic to topical drugs or cell preparations 6) Screening subjects with a history of prescription drug abuse, illegal drug abuse, and alcohol abuse within the previous 6 months 7) Alcohol or drug abuse 8) Pregnancy or lactation period 9) Participated in other clinical studies within the first 3 months of screening 10) The researcher believes that any situation that may result in participation in the study not being in the best interests of the subjects or may prevent, restrict, or confuse the safety or efficacy evaluation specified in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Evaluation;Grading of radiation-induced skin injury;Healing rate of radiation-induced skin injury wounds;Score scoring for grading radiation-induced skin injury; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cytokine levels;Pain in the skin exposed to radiation;Quality of Life Status; | — |
Countries
China
Contacts
Public ContactDong Jian
Yunnan Cancer Hospital / The Third Affiliated Hospital of Kunming Medical University
Outcome results
None listed