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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Pakistan
Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC)
RECRUITING
Lahore
Contact Information
Primary
Azra Mehmood, PhD
azra_mehmood@hotmail.com
+92-333-4107008
Backup
Amna Arif, M.Phil.
amnaarif.qureshi@gmail.com
+92-333-4161068
Time Frame
Start Date: 2020-11-20
Estimated Completion Date: 2025-12
Participants
Target number of participants: 28
Treatments
Active_comparator: Control; Standard-of-care management
Saline dressing will be done as a routine care management.
Experimental: Only PRP injection
Only PRP will be injected at the wound site.
Experimental: PRP + SVF injection
SVF pellet mixed with PRP will be injected at the wound site after adjusting number of cells.
Experimental: PRP + ASCs injection
Cultured ASCs mixed with PRP will be injected at the wound site after adjusting number of cells.
Sponsors
Collaborators: Jinnah Burn and Reconstructive Surgery Centre, Lahore, Higher Education Commission (Pakistan), Centre of Excellence in Molecular Biology, University of the Punjab, Lahore
Leads: University of the Punjab

This content was sourced from clinicaltrials.gov