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

Phase 1

• Conditions: Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic Wounds
• Interventions: Biological: fibroblast growth factor; Biological: Stem cell-derived derived pleiotropic factor

• Registration Number: NCT04235868
• Lead Sponsor: Chinese PLA General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-20
• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-18
• Study First Posted: 2020-01-22
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-09
• Last Update Posted: 2020-05-12
• Primary Completion: 2020-08-30
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	fibroblast growth factor	-
experimental group	Stem cell-derived derived pleiotropic factor	-

Primary Outcome Measures

Name	Time	Method
wound healing rate	1 month	Original wound area minus unhealed wound area then divided by original wound area

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China