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

University of the Punjab

Status and phase: Enrolling; Phase 1

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

Treatments: Biological: Only PRP injection; Biological: PRP + ASCs injection; Other: Control; Standard-of-care management; Biological: PRP + SVF injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05610865

CEMB-SC02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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 > 0.5.
• Already following an adequate off-loading method
• Provided signed informed consent

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

28 participants in 4 patient groups

Control; Standard-of-care management

Active Comparator group

Description:

Saline dressing will be done as a routine care management.

Treatment:

Other: Control; Standard-of-care management

Only PRP injection

Experimental group

Description:

Only PRP will be injected at the wound site.

Treatment:

Biological: Only PRP injection

PRP + SVF injection

Experimental group

Description:

SVF pellet mixed with PRP will be injected at the wound site after adjusting number of cells.

Treatment:

Biological: PRP + SVF injection

PRP + ASCs injection

Experimental group

Description:

Cultured ASCs mixed with PRP will be injected at the wound site after adjusting number of cells.

Treatment:

Biological: PRP + ASCs injection