Autologous Adipose Tissue Derived Stromal Vascular Fraction Versus Cultured Adipose Derived Stem Cells for the Treatment of Chronic Diabetic Wounds
Overview
- Phase
- Phase 1
- Intervention
- Control; Standard-of-care management
- Conditions
- Diabetic Foot Ulcer
- Sponsor
- University of the Punjab
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Interview and visual inspection of ulcers recovery rate
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The aim of this study is to evaluate the therapeutic efficacy of uncultured adipose derived stromal vascular fraction (SVF) and cultured adipose derived stem cells (ASCs) both supplemented with platelet rich plasma (PRP) to treat chronic diabetic foot ulcers. It will increase the pragmatic potential of both types of cells as PRP is rich in survival and chemotactic factors. Moreover, the autologous nature of the proposed study will ensure safety of its use in diabetic patients and will unveil the more effective therapeutic option for treatment of foot ulcer wounds.
Detailed Description
Under local or general anesthesia, autologous fat will be harvested by using a manual aspiration or syringe-assisted technique. SVF and ASCs isolation from autologous lipoaspirates will be done by enzymatic digestion method (collagenase Type-1 solution for 45 minutes at 37°C). Cell quality assessment will be done prior to transplantation by trypan blue exclusion assay and total populations and fractions of cells identified by immunocytochemistry / flow cytometry. PRP will be derived by centrifugation from 50-100ml blood collected in anticoagulant carrying bag, from patient at the day of transplantation. The injection volume will depend on the wound area of each patient. 2 million cells/ 0.5 ml PRP will be mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.
Investigators
Azra Mehmood
Associate Professor
University of the Punjab
Eligibility Criteria
Inclusion Criteria
- •Type 1 or Type 2 Diabetes Mellitus
- •Age 20-60 years (Male/Female)
- •Body mass index 20-30 kg/m2
- •Suitable for liposuction
- •Condition or Disease: Diabetic Neuropathy
- •Wound Type: Chronic foot ulcer
- •Approx. wound area: 2 cm2 - 8 cm2
- •Wound Condition should be of Wagner's grade I (Limited to soft tissue)
- •Duration of wound persistence: 6-24 Weeks
- •Transcutaneous oxygen pressure \> 30 mmHg, and an ankle brachial pressure index \> 0.
Exclusion Criteria
- •Uncontrolled hyperglycemia (HbAlc \> 9%)
- •Presence of severe clinical sign of infection
- •Inability to tolerate off-loading, and poor prognosis diseases including malignant tumors.
- •Serious chronic disease i.e hepatic, heart, renal, pulmonary diseases
- •Patients with critical limb ischemia and osteomylitis
- •Withdrawal of informed consent
Arms & Interventions
Control; Standard-of-care management
Saline dressing will be done as a routine care management.
Intervention: Control; Standard-of-care management
Only PRP injection
Only PRP will be injected at the wound site.
Intervention: Only PRP injection
PRP + SVF injection
SVF pellet mixed with PRP will be injected at the wound site after adjusting number of cells.
Intervention: PRP + SVF injection
PRP + ASCs injection
Cultured ASCs mixed with PRP will be injected at the wound site after adjusting number of cells.
Intervention: PRP + ASCs injection
Outcomes
Primary Outcomes
Interview and visual inspection of ulcers recovery rate
Time Frame: 3 months
This will be done in terms of diameter (cm2) of wounds, monitored in both cell transplanted and standard care patients after week interval till 3 months.
Secondary Outcomes
- Percentages (%) of wound closure rate (with respect to time) will be assessed.(3 months)