NCT05610865

Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers

Autologous Adipose Tissue Derived Stromal Vascular Fraction Versus Cultured Adipose Derived Stem Cells for the Treatment of Chronic Diabetic Wounds

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: University of the Punjab · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcer
• Diabetes Mellitus
• Diabetic Foot
• Diabetic Foot Infection
• Diabetic Foot Ulcer Neuropathic
• Foot Ulcer Due to Type 1 Diabetes Mellitus
• Foot Ulcer Due to Type 2 Diabetes Mellitus
• Foot Ulcer
• Diabetes Complications
• Chronic Diabetic Ulcer of Left Foot
• Chronic Diabetic Foot Ulcer of Right Foot

Interventions

Type	Name	Description
OTHER	Control; Standard-of-care management	Patients will undergo conventional wound care management.
BIOLOGICAL	Only PRP injection	Only PRP injected / cm2 intradermally at the border zone \& inside of wound surface bed.
BIOLOGICAL	PRP + SVF injection	Uncultured cells (SVF) along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.
BIOLOGICAL	PRP + ASCs injection	Cultured ASCs along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.

Timeline

• Start date: 2020-11-20
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-11-09
• Last updated: 2024-12-31

Locations

1 site across 1 country: Pakistan