Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells

NCT03865394 | Completed Phase 1 DMC

• 5 other identifiers: 1ABC Therapy267976/13/NCBR/20152016-004109-15PL008125Z4217
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate efficiency of applying of adipose-derived mesenchymal stem cells (ADSC) in treatment of chronic wounds in diabetic foot syndrome.

Conditions

Diabetic Foot Ulcer

Keywords

stromal vascular fraction; adipose-derived mesenchymal stem cells; chronic wounds; diabetes; foot ulcer

Outcome Measures

Primary Outcomes (1)

• Changes in wound size

  The comparison of the time required for the 50% reduction of initial wound size between patients in both study arms. The wound size changes will be assessed using digital 3D wound imaging medical device with image processing software, according to the following rules: * for wounds deeper than 0.5 cm - measurement of wound volume, or * for shallow wounds (less than 0.5 cm depth) - measurement of wound surface.

  8 weeks

Secondary Outcomes (5)

• Changes in wound morphology

  8 weeks

• Changes in pro-angiogenic factors expression

  8 weeks

• Changes in wound-associated pain

  8 weeks

• Changes in the quality of life

  8 weeks

• Record of adverse events

  8 weeks

Study Arms (2)

Allogeneic ADSC cells in fibrin solution

EXPERIMENTAL

Application of allogeneic ADSC stem cells in fibrin gel, to cover wound surface with thin cells layer. Therapy is based on standard procedure of diabetic foot ulcer treatment combined with application of allogeneic ADSC stem cells in fibrin solution onto the wound surface.

Biological: Application of allogeneic ADSC stem cells in fibrin gel

Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface.

ACTIVE COMPARATOR

Application of fibrin gel to cover wound surface.

Procedure: Standard care in diabetic foot ulcer

Interventions

Application of allogeneic ADSC stem cells in fibrin gel BIOLOGICAL

Chronic wounds in diabetic foot ulcer will be covered with ADSC suspended in fibrin gel - single dose will be administered followed by weekly wound control.

Allogeneic ADSC cells in fibrin solution

Standard care in diabetic foot ulcer PROCEDURE

Chronic wounds in diabetic foot ulcer will be covered with fibrin gel followed by weekly wound control.

Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing informed consent form.
• Above the age of 18
• Voluntary participation in the research, following the requirements of the protocol and acceptance for procedures related with its implementation
• Chronic wound in the course of diabetic foot syndrome, with the wound surface between 1 - 25 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
• Blood level of glycated haemoglobin (HbA1c) \<=11%
• Satisfactory blood supply to the wound verified by the measurement of the oxygen level in the foot tissue (\>=30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (\>=50 mmHg) of the affected limb.
• General health condition, which according to the investigator's opinion, allows patient's participation in all study procedures.

You may not qualify if:

• Lack of patient's cooperation
• Wound etiology other than diabetic foot syndrome
• Clinicaly significant limb ischemia as verified by the measurement of the oxygen level in the foot tissue (\<30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (\<50 mmHg)
• Active wound infection, which would require the treatment with antibiotics
• Known allergy to ingredients of study product (thrombin, penicillin).
• Active venous thromboembolism
• Any systemic disease (acute or chronic) in the stage of exacerbation or not stabilized, that in the opinion of the investigator may hinder or make impossible a patient's participation in the study
• Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission occured less than 5 years before joining the study

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Polish Stem Cells Bank S.A.: collaborator

Study Sites (1)

Medical University of Warsaw, Department of Diabetology and Internal Diseases

Warsaw, Poland

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Foot Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Beata Mrozikiewicz-Rakowska, . Assoc.Prof.

  Medical University of Warsaw, Department of Diabetology and Internal Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: March 6, 2019
• Study Start: July 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: September 30, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-09

Locations

PL (1)