NCT04235868

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic Wounds

Interventions

Type	Name	Description
BIOLOGICAL	Stem cell-derived derived pleiotropic factor	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.
BIOLOGICAL	fibroblast growth factor	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.

Timeline

• Start date: 2019-10-20
• Primary completion: 2020-08-30
• Completion: 2020-10-30
• First posted: 2020-01-22
• Last updated: 2020-05-12

Locations

1 site across 1 country: China