Completed

DIALEGAutologous Bone Marrow Aspirate Concentrate (BMAC) for No-option Critical Limb Ischemia in Type-II Diabetes Mellitus Patients

Study Aim

This study aims to evaluate the safety and efficacy of using Autologous Bone Marrow Aspirate Concentrate (BMAC) as a treatment for no-option critical limb ischemia in patients with Type-II Diabetes Mellitus, primarily focusing on amputation-free survival over the first 18 months.

What is being tested

Group A: Intramuscular

+ Group B: Intraarterial

+ Group C: Intravenous

BiologicalProcedure

Who is being recruted

Endocrine System Diseases+5

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

Over 18 Years

+20 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2 & 3

Interventional

Study Start: September 2012

See protocol details

Summary

Principal SponsorUniversity Hospital Ostrava

Last updated: September 30, 2021

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

Secondary hypothesis assumes, that the intravenous application of BMAC in patients with T2DM older than 30 years of age, with a dose of insulin exceeding 0.7 U/kg/day or 50U/day will result in decreasing the insulin dose in the course of 6-month follow-up and in an improvement of the glycHBA1c levels, improvement of the liver and kidney function, decrease of the cholesterol levels and improvement of the immune response parameters, i.e. parameters of lymphocytar blastic transformation, more than in case of patients with intramuscular or intraarterial application of BMAC.

NCT01818310

Principal SponsorUniversity Hospital Ostrava

Last updated: September 30, 2021

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersDiabetes MellitusIschemia

Criteria

9 inclusion criteria required to participate

ABI value < 50 mmHg or ABI < 0.4

TBI value < 40 mmHg or TBI < 0.4

TcPO2 < 20 mmHg in supine position

age > 18 years

Show More Criteria

11 exclusion criteria prevent from participating

active infectious disease, or ATB treatment

anticipated life expectancy < 6 months

health risks excluding the possibility of general anaesthesia or sedation

history of bone-marrow disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Intramuscular BMAC application The study subjects in the Group A will receive a treatment of 35ml BMAC administered intramuscularly into the affected limb, in individual punctures of 1 ml. The punctures will be applied into the crural muscle around the defect, the procedure takes approx. 60 minutes.

Group II

Experimental

Intraarterial BMAC application The study subjects in the Group B will receive a treatment of 35ml BMAC administered intraarterially into the affected limb.

Group III

Experimental

Group C: Intravenous The study subjects in the Group C will receive a treatment of 35ml BMAC administered intravenously into the affected limb.

Group IV

Group D: Control Group Study subjects in Group D will receive a standard treatment for NO-option CLI.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Hospital Ostrava

Ostrava, CzechiaOpen University Hospital Ostrava in Google Maps

CompletedOne Study Center