Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Non-healing Wounds

Study Overview
=================
Brief Summary
-----------------
Chronic wounds do not heal for prolonged periods of time with the significant financial burden on the healthcare system. It has become increasingly essential to improve our clinical treatments. The most promising potential treatment options rely on stem cell-based therapies. A large body of evidence indicates that mesenchymal stem cells can promote wound closure of chronic wounds in animal models and in preclinical studies. MSCs efficacy depends mostly on their paracrine activity. All the bioactive factors and cytokines in MSCs secretions constitute can be collected in the conditioned medium. In here, stem cell-derived conditioned medium was further made into a lyophilized powder. Patients with chronic wounds were enrolled. The wounds in control group treated with fibroblast growth factor commonly used in clinical practice. The wounds in experimental group treated with lyophilized powder. The effectiveness and safety of lyophilized powder will evaluate for chronic wounds.

Official Title
-----------------
Clinical Trial of Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Non-healing Wounds

Conditions
-----------------
Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic Wounds

Intervention / Treatment
-----------------
* Biological: Stem cell-derived derived pleiotropic factor
* Biological: fibroblast growth factor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of chronic wounds; Male or female over 17; Psychologically stable and able to complete the experimental process. - Exclusion Criteria: wound greater than 10cm ×10cm; Exposure to radiation or use of hormones, chemotherapy, growth factor dressings and immunosuppressants within 3 months; Participated in other similar tests within 3 months; Pregnant, or lactating women; Severe infectious disease; Severe heart, liver, and kidney dysfunction; Had a history of cancer -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br> | Biological: fibroblast growth factor<br>* After debridement, the wounds in control group apply fibroblast growth factor to the wound surface, and use foam dressing to wrap the wound; apply once every 2-3 days.<br>|
| Experimental: experimental group<br> | Biological: Stem cell-derived derived pleiotropic factor<br>* After debridement, the wounds in experimental group apply stem cell-derived lyophilized powder, and use foam dressing to wrap the wound; apply once every 2-3 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing rate | Original wound area minus unhealed wound area then divided by original wound area | 1 month |