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Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Residual Burn Wound

Evaluation of the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Residual Burn Wound

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04235296
Enrollment
30
Registered
2020-01-21
Start date
2019-11-17
Completion date
2021-06-30
Last updated
2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Residual Burn Wound

Brief summary

Treatment of extensive deep burn residual wounds is a common problem in burn plastic surgery. Due to bacterial invasion, excessive maturation of granulation tissue, poor abrasion resistance of new epithelium, and coexistence of wound healing and dissolution can lead to delayed wound healing. Residual wounds rarely heal spontaneously and are prone to recurrence. Mesenchymal stem cells (MSC) boost tissue repair through paracrine. Many biological effectors, including IGF-1, vascular endothelial growth factor (VEGF), TGF-β1 have been found in MSC conditioned media (MSC-CM), and play a role in promoting tissue repair and regeneration.Our previous animal experiments have confirmed the role of MSC-CM in regulating wound inflammation, repairing damaged repair cells and promoting wound regeneration. In here, we will evaluate the safety and effectiveness of mesenchymal stem cell conditioned medium-derived pleiotropic factor in treating residual burn wound.

Interventions

BIOLOGICALepidermal growth factor

Residual wounds from the same person were divided into control group and experimental group. The epidermal growth factor is used to control group. Then the foam wound dressing was selected to cover the residual wound, and the dressing was changed every 2 days.

Residual wounds from the same person were divided into control group and experimental group. The pleiotropic factor is used to control group. Then the foam wound dressing was selected to cover the residual wound, and the dressing was changed every 2 days.

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

Patients with thermal burns are all residual wounds that have not healed after 1 month; The distance between adjacent residual wounds of the same patient is greater than 10cm; Patients signing informed consent -

Exclusion criteria

Patients with severe heart, lung, liver, kidney, blood and mental system diseases; Combined with diabetes, hypertension and malnutrition; Patients with shock, severe systemic infections, and pregnant or lactating women. -

Design outcomes

Primary

MeasureTime frameDescription
wound healing rate2 monthsOriginal wound area minus unhealed wound area divided by original wound area

Countries

China

Contacts

Primary ContactMeirong Li, doctor
meirong811225@126.com010-66936345

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026