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

Primary Purpose

Diabetic Foot Ulcer, Diabetes Mellitus, Diabetic Foot

Status

Recruiting

Phase

Phase 1

Locations

Pakistan

Study Type

Interventional

Intervention

Control; Standard-of-care management

Only PRP injection

PRP + SVF injection

PRP + ASCs injection

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Stromal vascular fraction (SVF), Adipose derived stem cells (ASCs), Diabetic foot ulcer (DFU), Platelet rich plasma (PRP)

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Control; Standard-of-care management

Only PRP injection

PRP + SVF injection

PRP + ASCs injection

Arm Description

Saline dressing will be done as a routine care management.

Only PRP will be injected at the wound site.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Change in wound size (cm2) will be determined

Full Information

NCT ID

NCT05610865

First Posted

October 26, 2022

Last Updated

November 3, 2022

Sponsor

University of the Punjab

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05610865

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 20, 2020 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of the Punjab

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control; Standard-of-care management

Arm Type

Active Comparator

Arm Description

Saline dressing will be done as a routine care management.

Arm Title

Only PRP injection

Arm Type

Experimental

Arm Description

Only PRP will be injected at the wound site.

Arm Title

PRP + SVF injection

Arm Type

Experimental

Arm Description

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

Arm Title

PRP + ASCs injection

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Control; Standard-of-care management

Intervention Description

Patients will undergo conventional wound care management.

Intervention Type

Biological

Intervention Name(s)

Only PRP injection

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

PRP + SVF injection

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

PRP + ASCs injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Interview and visual inspection of ulcers recovery rate

Description

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.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Description

Change in wound size (cm2) will be determined

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Azra Mehmood, PhD

Phone

+92-333-4107008

azra_mehmood@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Amna Arif, M.Phil.

Phone

+92-333-4161068

amnaarif.qureshi@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Azra Mehmood, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sheikh Riazuddin, PhD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Lahore

State/Province

Punjab

ZIP/Postal Code

54550

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr. Moazzam Nazeer Tarar, Plastic Surgeon MBBS/ FRCS

Phone

+92-300-8423139

mntarar@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33199085

Citation

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.

Results Reference

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PubMed Identifier

34169656

Citation

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.

Results Reference

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PubMed Identifier

33826245

Citation

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.

Results Reference

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PubMed Identifier

27219884

Citation

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.

Results Reference

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PubMed Identifier

20492632

Citation

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.

Results Reference

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PubMed Identifier

29715071

Citation

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.

Results Reference

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Citation

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.

Results Reference

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PubMed Identifier

32723090

Citation

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.

Results Reference

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PubMed Identifier

29256523

Citation

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.

Results Reference

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PubMed Identifier

32131655

Citation

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.

Results Reference

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

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