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

Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04235868
• Other study ID #: MP-01
• Status: Recruiting
• Phase: Phase 1
• Start date: October 20, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: May 2020
• Source: Chinese PLA General Hospital
• Contact: Meirong Li, doctor
• Phone: 010-66936345
• Email: meirong811225[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic Wounds
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing rate	Original wound area minus unhealed wound area then divided by original wound area	1 month