Safety and Efficacy Study of Autologous Bone Marrow Aspirate Concentrate for No-Option Critical Limb Ischemia (DIALEG)

University Hospital Ostrava

Status and phase

Completed

Phase 3

Phase 2

Conditions

Type-2 Diabetes Mellitus

Critical Lower Limb Ischemia

Treatments

Biological: Group A: Intramuscular

Procedure: Group D: Surgical endovascular treatment with maximum medicamentous treatment

Biological: Group C: Intravenous

Biological: Group B: Intraarterial

Study type

Interventional

Funder types

Other

Identifiers

NCT01818310

2012-T2DM-CLI

2012-001825-28 (EudraCT Number)

Details and patient eligibility

About

The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity in patients with diabetes mellitus type II., intraarterially into the defect of the limb or with an intravenous application only, has a greater potential to improve the perfusion in the ischemic limbs than standard treatment of NO-CLI. Another aim of the study is to find out differences among three different therapeutic types of BMAC application, to define their effectiveness and safety and to compare the impact of different means of application to the speed of healing of the limb defects and the improvement of perfusion parameters.

Full description

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

type 2 diabetes mellitus
diagnosis of critical limb ischemia
non-healing defect on the study limb
ABI value < 50 mmHg or ABI< 0.4
TBI value < 40 mmHg or TBI < 0.4
TcPO2 < 20 mmHg in supine position
no other suitable surgical or re-vascularization procedure
age > 18 years
signed Informed Consent

Exclusion criteria

non-signing of the Informed Consent
anticipated life expectancy < 6 months
history of bone-marrow disease
renal failure or dialysis dependency
known malignant disease
health risks excluding the possibility of general anaesthesia or sedation
life-threatening ischaemic heart disease
vast necrosis of the index limb
active infectious disease, or ATB treatment
treatment with immunosupressives
pregnancy, breastfeeding

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 4 patient groups

Group A: Intramuscular

Experimental group

Description:

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.

Treatment:

Biological: Group A: Intramuscular

Group B: Intraarterial

Experimental group

Description:

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

Treatment:

Biological: Group B: Intraarterial

Group C: Intravenous

Experimental group

Description:

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

Treatment:

Biological: Group C: Intravenous

Group D: Control-standard treatment

Other group

Description:

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