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

November 3, 2022 updated by: Azra Mehmood, University of the Punjab

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54550
        • Recruiting
        • Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC)
        • Contact:
          • Dr. Moazzam Nazeer Tarar, Plastic Surgeon MBBS/ FRCS
          • Phone Number: +92-300-8423139
          • Email: mntarar@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control; Standard-of-care management
Saline dressing will be done as a routine care management.
Other: Control; Standard-of-care management
Patients will undergo conventional wound care management.
Experimental: Only PRP injection
Only PRP will be injected at the wound site.
Biological: Only PRP injection
Only PRP injected / cm2 intradermally at the border zone & inside of wound surface bed.
Experimental: PRP + SVF injection
SVF pellet mixed with PRP will be injected at the wound site after adjusting number of cells.
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.
Experimental: PRP + ASCs injection
Cultured ASCs mixed with PRP will be injected at the wound site after adjusting number of cells.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentages (%) of wound closure rate (with respect to time) will be assessed.
Time Frame: 3 months
Change in wound size (cm2) will be determined
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Punjab

Collaborators

Higher Education Commission (Pakistan)
Centre of Excellence in Molecular Biology, University of the Punjab, Lahore
Jinnah Burn and Reconstructive Surgery Centre, Lahore

Investigators

  • Study Director: Sheikh Riazuddin, PhD, Jinnah Burn and Reconstructive Surgery Center (JB&RSC), Lahore
  • Principal Investigator: Azra Mehmood, PhD, Center of Excellence in Molecular Biology (CEMB, University of the Punjab, Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2020

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 9, 2022

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEMB-SC02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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