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

NCT05610865 | Recruiting Phase 1 DMC

• 1 other identifier: CEMB-SC02
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Stromal vascular fraction (SVF), Adipose derived stem cells (ASCs), Diabetic foot ulcer (DFU), Platelet rich plasma (PRP)

Outcome Measures

Primary Outcomes (1)

• Interview and visual inspection of ulcers recovery rate

  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 Outcomes (1)

• Percentages (%) of wound closure rate (with respect to time) will be assessed.

  3 months

Study Arms (4)

Control; Standard-of-care management

ACTIVE COMPARATOR

Saline dressing will be done as a routine care management.

Other: Control; Standard-of-care management

Only PRP injection

EXPERIMENTAL

Only PRP will be injected at the wound site.

Biological: Only PRP injection

PRP + SVF injection

EXPERIMENTAL

SVF pellet mixed with PRP will be injected at the wound site after adjusting number of cells.

Biological: PRP + SVF injection

PRP + ASCs injection

EXPERIMENTAL

Cultured ASCs mixed with PRP will be injected at the wound site after adjusting number of cells.

Biological: PRP + ASCs injection

Interventions

Control; Standard-of-care management OTHER

Patients will undergo conventional wound care management.

Control; Standard-of-care management

Only PRP injection BIOLOGICAL

Only PRP injected / cm2 intradermally at the border zone \& inside of wound surface bed.

Only PRP injection

PRP + SVF injection BIOLOGICAL

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.

PRP + SVF injection

PRP + ASCs injection BIOLOGICAL

Cultured ASCs along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.

PRP + ASCs injection

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Lahore, Punjab Province, 54550, Pakistan

RECRUITING

Related Publications (10)

• Shao S, Pan R, Chen Y. Autologous Platelet-Rich Plasma for Diabetic Foot Ulcer. Trends Endocrinol Metab. 2020 Dec;31(12):885-890. doi: 10.1016/j.tem.2020.10.003. Epub 2020 Nov 13.

  PMID: 33199085 BACKGROUND

• Nolan GS, Smith OJ, Heavey S, Jell G, Mosahebi A. Histological analysis of fat grafting with platelet-rich plasma for diabetic foot ulcers-A randomised controlled trial. Int Wound J. 2022 Feb;19(2):389-398. doi: 10.1111/iwj.13640. Epub 2021 Jun 24.

  PMID: 34169656 BACKGROUND

• Carstens MH, Quintana FJ, Calderwood ST, Sevilla JP, Rios AB, Rivera CM, Calero DW, Zelaya ML, Garcia N, Bertram KA, Rigdon J, Dos-Anjos S, Correa D. Treatment of chronic diabetic foot ulcers with adipose-derived stromal vascular fraction cell injections: Safety and evidence of efficacy at 1 year. Stem Cells Transl Med. 2021 Aug;10(8):1138-1147. doi: 10.1002/sctm.20-0497. Epub 2021 Apr 7.

  PMID: 33826245 BACKGROUND

• Qin HL, Zhu XH, Zhang B, Zhou L, Wang WY. Clinical Evaluation of Human Umbilical Cord Mesenchymal Stem Cell Transplantation After Angioplasty for Diabetic Foot. Exp Clin Endocrinol Diabetes. 2016 Sep;124(8):497-503. doi: 10.1055/s-0042-103684. Epub 2016 May 24.

  PMID: 27219884 BACKGROUND

• Han SK, Kim HR, Kim WK. The treatment of diabetic foot ulcers with uncultured, processed lipoaspirate cells: a pilot study. Wound Repair Regen. 2010 Jul-Aug;18(4):342-8. doi: 10.1111/j.1524-475X.2010.00593.x. Epub 2010 May 11.

  PMID: 20492632 BACKGROUND

• Didangelos T, Koliakos G, Kouzi K, Arsos G, Kotzampassi K, Tziomalos K, Karamanos D, Hatzitolios AI. Accelerated healing of a diabetic foot ulcer using autologous stromal vascular fraction suspended in platelet-rich plasma. Regen Med. 2018 Apr;13(3):277-281. doi: 10.2217/rme-2017-0069. Epub 2018 May 1.

  PMID: 29715071 BACKGROUND

• Prakasam N, Prabakar MS, Reshma S, Loganathan K, Senguttuvan K. A clinical study of platelet rich plasma versus conventional dressing in management of diabetic foot ulcers. International Surgery Journal. 2018 Sep 25;5(10):3210-6.

  BACKGROUND

• Alvaro-Afonso FJ, Sanz-Corbalan I, Lazaro-Martinez JL, Kakagia D, Papanas N. Adipose-Derived Mesenchymal Stem Cells in the Treatment of Diabetic Foot Ulcers: A Review of Preclinical and Clinical Studies. Angiology. 2020 Oct;71(9):853-863. doi: 10.1177/0003319720939467. Epub 2020 Jul 29.

  PMID: 32723090 BACKGROUND

• Khan A, Junaid N. Prevalence of diabetic foot syndrome amongst population with type 2 diabetes in Pakistan in primary care settings. J Pak Med Assoc. 2017 Dec;67(12):1818-1824.

  PMID: 29256523 BACKGROUND

• Yin S, Yang X, Bi H, Zhao Z. Combined Use of Autologous Stromal Vascular Fraction Cells and Platelet-Rich Plasma for Chronic Ulceration of the Diabetic Lower Limb Improves Wound Healing. Int J Low Extrem Wounds. 2021 Jun;20(2):135-142. doi: 10.1177/1534734620907978. Epub 2020 Mar 4.

  PMID: 32131655 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Foot Ulcer; Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Foot Diseases

Study Officials

• Azra Mehmood, PhD

  Center of Excellence in Molecular Biology (CEMB, University of the Punjab, Lahore

  PRINCIPAL INVESTIGATOR

• Sheikh Riazuddin, PhD

  Jinnah Burn and Reconstructive Surgery Center (JB&RSC), Lahore

  STUDY DIRECTOR

Central Study Contacts

Azra Mehmood, PhD

CONTACT

+92-333-4107008; azra_mehmood@hotmail.com

Amna Arif, M.Phil.

CONTACT

+92-333-4161068; amnaarif.qureshi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 9, 2022
• Study Start: November 20, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

PA (1)