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

Last updated: December 30, 2024
Sponsor: University of the Punjab
Overall Status: Active - Recruiting

Phase

1

Condition

Pressure Ulcer

Diabetes Mellitus, Type 2

Ulcers

Treatment

PRP + ASCs injection

PRP + SVF injection

Control; Standard-of-care management

Clinical Study ID

NCT05610865
CEMB-SC02
  • Ages 20-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Uncontrolled hyperglycemia (HbAlc > 9%)

  • Presence of severe clinical sign of infection

  • Inability to tolerate off-loading, and poor prognosis diseases including malignanttumors.

  • Serious chronic disease i.e hepatic, heart, renal, pulmonary diseases

  • Patients with critical limb ischemia and osteomylitis

  • Withdrawal of informed consent

Study Design

Total Participants: 28
Treatment Group(s): 4
Primary Treatment: PRP + ASCs injection
Phase: 1
Study Start date:
November 20, 2020
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC)

    Lahore, Punjab 54550
    Pakistan

    Active - Recruiting

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