chronic wounds
Conditions
Interventions
Treatment :Conventional standard therapy and intramuscular injection of autologous adipose-derived stem/stromal cells
Control :Conventional standard therapy
Sponsors
Renmin Hospital, Hubei University of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Female or male patient 18 to 75 years of age with diagnosis chronic wounds; 2) Patients must understand and give written informed consent; 3) Patient's wound has been refractory to conventional therapy with no measurable signs of healing for at least 30 days; 4) Ulcer size must be less than or equal to 15 cm2 at randomization (after mechanical debridement of the ulcer); 5) Subject must have negative testing results prior to start of clinical trial: a. hemoccult b. chest x-ray or CT chest and CT abdomen/ pelvis (at least 3 months prior to start of clinical trial); c. tumor markers: CEA, AFP, CA19-9., PSA (for male), CA 125 (for female); d. for female patients: TCT and mammogram (at least 3 months prior to start of clinical trial). 6) Menopausal female patients or received hysterectomy, premenopausal female-negative beta hcg; 7) Able to follow physician instructions on medication and diet; 8) Subject has adequate (>200cc) abdominal or other subcutaneous adipose tissue accessible by syringe-based lipoharvest.
Exclusion criteria
Exclusion criteria: 1) The patient is pregnant or breast-feeding; 2) Patient receiving cytotoxic agents 30 days prior to start of clinical trial; 3) Requirement for the use of systemic corticosteroids or immuno- suppressive agents; 4) The patient has a history of active, systemic malignancy; 5) The patient is known to be HIV positive, Hepatitis B or C positive; 6) Glycosylated hemoglobin A1C (HbA1C) is > 11%; 7) Life expectancy 160 mmhg, diastolic blood pressure >100 mmhg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse effects;The percentage of Wound closure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound Dimension Decreases;pain;SF-36;Change in Gene Expression Analysis/ Change in Bacterial Counts; | — |
Countries
China
Contacts
Public ContactBin Zhou
Hubei Provincial Renmin Hospital
Outcome results
None listed