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

NCT05610865 · University of the Punjab

Recruiting

In plain English

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Official title

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

About this study

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.

Eligibility criteria

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 design

Enrollment target: 28 participants

Allocation: randomized

Masking: none

Age groups: adult

Timeline

Starts: 2020-11-20

Estimated completion: 2025-12

Last updated: 2024-12-31

Interventions

Other: Control; Standard-of-care managementBiological: Only PRP injectionBiological: PRP + SVF injectionBiological: PRP + ASCs injection

Primary outcomes

• Interview and visual inspection of ulcers recovery rate (3 months)

Sponsor

University of the Punjab · other

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

Contacts & investigators

ContactAzra Mehmood, PhD · contact · azra_mehmood@hotmail.com · +92-333-4107008

ContactAmna Arif, M.Phil. · contact · amnaarif.qureshi@gmail.com · +92-333-4161068

InvestigatorAzra Mehmood, PhD · principal_investigator, Center of Excellence in Molecular Biology (CEMB, University of the Punjab, Lahore

InvestigatorSheikh Riazuddin, PhD · study_director, Jinnah Burn and Reconstructive Surgery Center (JB&RSC), Lahore

All locations (1)

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

Lahore, Punjab Province, Pakistan

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