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

Sponsor

University of the Punjab (Other)

Overall Status

Recruiting

CT.gov ID

NCT05610865

Collaborator

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

Enrollment

Location

Arms

36.3

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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	Other: Control; Standard-of-care management Biological: Only PRP injection Biological: PRP + SVF injection Biological: PRP + ASCs injection	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 20, 2020

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Interview and visual inspection of ulcers recovery rate [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.

Secondary Outcome Measures

Percentages (%) of wound closure rate (with respect to time) will be assessed. [3 months]
Change in wound size (cm2) will be determined

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC)	Lahore	Punjab	Pakistan	54550

Sponsors and Collaborators

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

Investigators

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