Cell Therapy for Diabetic Foot Ulcer

Randomized, Controlled Phase II Clinical Study to Evaluate Superiority of "InbioDerm+C" Autologous Stem Cell-Based Therapy Plus Advanced Healing Compared With Advanced Healing in Diabetic Foot Ulcer Patients

Diabetes is a highly prevalent chronic disease that affects a large part of the world's population. Among the most costly complications is the diabetic foot ulcer, where its decompensation can result in limb amputation, a risk 10 to 20 times more frequent for diabetic population. Two underlying pathophysiological mechanisms are mainly identified: neuropathy and problems associated with vasculature and blood supply, in addition to the incidence of infections, which further impairs prognosis. Skin regeneration involves several overlapping and consecutive stages, which in the case of a diabetic patient are altered.

Although healing protocols have been significantly improved at the country level, and there is also a large amount of medical supplies for treatment of these wounds, there are still patients with ulcers refractory to this care that end in amputation. In response to this, new treatments have emerged that use biomaterials and cells of the patient himself, which attempt to emulate the architecture and functionality of normal tissue. Cell therapy has gained strength in recent years, with more and more studies indicating the positive effect of cell application on healing of chronic wounds with underlying pathologies, such as diabetes.

The product to be evaluated corresponds to a combined medical device, which conveys a cellular therapy, known as InbioDerm+C. The purpose of this Phase II clinical study is to determine whether InbioDerm+C treatment plus advanced healing is equal to or superior to advanced healing in a diabetic population with Wagner II grade foot ulcer treated in Villa Alemana primary care family centers, Las Américas, Juan Bautista Bravo Vega and Eduardo Frei.

Study Overview

• Status: Recruiting
• Conditions: Wound Heal; Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus
• Intervention / Treatment: Procedure: Advanced healing; Combination product: InbioDerm + C plus advanced healing

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Soledad Herrera; Phone Number: 56966083093; Email: soledadherrera@inbiocriotec.cl
• Study Contact Backup: Name: Caroline Weinstein-Oppenheimer; Phone Number: 56322508140; Email: caroline.weinstein@uv.cl

Study Locations

• Chile
  • Valparaíso
    • Villa Alemana, Valparaíso, Chile, 2550880
      • Recruiting
      • Centro de Salud Familiar de Villa Alemana
      • Contact: Franco Ahumada, MD; Phone Number: 56965487096; Email: franco.ahumada@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient over 18 years old and under 75 years old.
• Patient diagnosed with DM type II.
• Patient with negative pregnancy test.
• Ulcer size with area between 1 cm2 and 12 cm2.
• Ulcer with Wagner grade II classification with less than 50% slough and no tendon exposure, validated by an external specialist after ulcer debridement.
• Ulcer age ≥ at one month.
• Patients with palpable posterior tibial and pedial pulse

Exclusion Criteria:

• Patients with non-diabetic ulcers.
• Toe ulcers.
• Patient with grade IV and V renal insufficiency.
• Pregnant or breastfeeding women, or those who are planning to conceive children.
• Clinical evidence of infection.
• Any condition or circumstance that might interfere with adherence to the treatment regimen (compliance with scheduled visits, psychiatric disorders, or drug and/or alcohol abuse)
• History of hepatitis B or hepatitis C and HIV (by internal laboratory biosafety protocols)
• Allergy to penicillin, streptomycin, and gentamicin
• Subjects undergoing treatment with immunosuppressants and corticoids.
• Subjects on anticoagulant treatment with acenocoumarol and warfarin.
• Having received any experimental treatment in the last three months (drug, biological product, medical device or cell therapy), except for the use of vaccines administered against COVID-19 (e.g. mRNA technologies, viral vector or inactivated virus).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Advanced Healing; Activities related to wound washing, microbiological load control, care of peri-ulcer tissue and application of wound healing products in accordance to condition of the ulcer	Procedure: Advanced healing; Patients who are assigned to active comparator correspond to the control treatment, which will be received advanced healing.
EXPERIMENTAL: InbioDerm + C plus advanced healing; For patient who are assigned treatment with InbioDerm+C plus advanced healing a section of skin tissue and peripheral venous blood will be taken. From the skin section and through an enzymatic process with cell proliferation, skin cells will be obtained that will be integrated into de the InbioDerm+C, then will be apply to the patients with the advanced wound healing every fourteen days in accordance application program.	Combination product: InbioDerm + C plus advanced healing; For patients who are assigned to experimental treatment with InbioDerm+C plus advanced healing a section of skin tissue and peripheral venous blood will be taken. From the skin section, through an enzymatic process and cell proliferation for a period of approximately fourteen days, the cells that are integrated in the InbioDerm+C will be obtained and used to treat the foot ulcer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with completely closed ulcers	The principal investigation and external evaluator will assess every fifteen days the wound closure status.	16 weeks

Collaborators and Investigators

• Sponsor: Instituto para el Desarrollo Biotecnológico y la Innovación S.A.
• Collaborators: Corporación de Fomento de la Producción, Chile
• Investigators: Principal Investigator: Franco Ahumada, Centro de Salud Familiar Villa Alemana

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2020
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): September 2, 2022

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (ACTUAL): February 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetes Mellitus, Type 2; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: INBIO EC 201903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No