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

C

Chinese PLA General Hospital (301 Hospital)

Status and phase

Unknown
Phase 1

Conditions

Mesenchymal Stem Cell-derived Bioactivator for Treating Chronic Wounds

Treatments

Biological: fibroblast growth factor
Biological: Stem cell-derived derived pleiotropic factor

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 -

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

control group
Active Comparator group
Treatment:
Biological: fibroblast growth factor
experimental group
Experimental group
Treatment:
Biological: Stem cell-derived derived pleiotropic factor

Trial contacts and locations

1

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Central trial contact

Meirong Li, doctor

Data sourced from clinicaltrials.gov

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