Application of Cord Blood Platelet Gel (CBPG) for the treatment of non-healing skin ulcers due to the cutaneous chronic GVHD
Phase 1
Recruiting
- Conditions
- nhealed skin ulcers in patients with chronic GVHD skin complications.Chronic graft-versus-host diseaseD89.811
- Registration Number
- IRCT20190101042197N1
- Lead Sponsor
- Royan Stem cell Technology Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Existence of chronic GvHD criteria after allogeneic hematopoietic stem cell transplantation
Wounds in the upper, lower and trunk
Wound surface area more than 2 cm2 and less than 5 cm2 with at least 6 weeks durability
Wound grading is 2 and 3.
Minimum age one year and maximum 15 years
Exclusion Criteria
Other diseases such as diabetes, allergies, coagulopathies or underlying diseases that involve the skin
Wounds are small (less than 1 cm) or very large (more than 5 cm)
Wound grade is 1 or 4.
Lesions on the face and neck
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduce wound surface area. Timepoint: At the beginning of the study and 7, 15 and 30 days after the start. Method of measurement: Direct view.;Causes severe allergic reactions. Timepoint: 1, 3 and 7 days after the intervention. Method of measurement: Direct view.;Infection. Timepoint: One week after intervention. Method of measurement: Sampling.;Reduced pain. Timepoint: One month after intervention. Method of measurement: direct examination.
- Secondary Outcome Measures
Name Time Method ormal physical activity. Timepoint: 6 month after intervention. Method of measurement: Direct examination and observation.