Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Poorly Healed Wounds of Postoperative Incision

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 1

Conditions: MSCs-PFs in Treating Poorly Healed Wounds of Postoperative Incision

Treatments: Biological: The pleiotropic factor derived from mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04538885

CHIN-PLAGH-MP-04

Details and patient eligibility

About

Poor incision healing is a common complication after abdominal surgery, mainly manifested as incision dehiscence, subcutaneous fat liquefaction, malnutrition, and incision infection. Poor healing of the incision will increase the patient's pain and prolong the patient's hospital stay, and the choice of wound treatment is closely related to the wound healing effect. Mesenchymal stem cells mainly rely on paracrine effects to exert their therapeutic effects and obtain better therapeutic effects in wound healing. Here, the pleiotropic factors secreted from mesenchymal stem cells (MSCs-PFs) will be used to treat patients with poor healing after surgery to evaluate its effectiveness and safety.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Wound size <10X10cm2, the wound base only involves subcutaneous and muscle tissue；
2. Underwent surgical treatment, all incisions were type I, and the incisions healed poorly and delayed healing after 1 week；
3. There is inflammatory reaction at the incision, but no clear indication of infection, or severe infection of the incision.After debridement and dressing change, the infection is controlled and the fresh granulation period is entered
4. Men or women older than 17 years old and younger than 75 years old;
5. Psychologically stable, able to complete the test process.

Exclusion criteria

1. Wound size>10X10cm2, the wound base is as deep as the chest and abdominal cavity, causing infection or osteomyelitis in the chest and abdominal cavity;
2. Surgical incision with purulent infection, local purulent secretions can be seen;
3. Those with obvious body temperature and white blood cell elevation, local purulent secretions have positive bacterial culture;
4. Patients with diabetes;
5. Glucocorticoid users;
6. Patients with immune dermatosis;
7. Neoplastic wounds, such as wounds after skin cancer resection, or skin wounds caused by tumor invasion;
8. Psycho-psychological disorders and poor compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

control group

No Intervention group

Description:

No intervention

experimental group

Experimental group

Description:

The pleiotropic factor derived from mesenchymal stem cells was smeared on the wound with a dosage of (2.5mg/2cm2)

Treatment:

Biological: The pleiotropic factor derived from mesenchymal stem cells