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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

September 30, 2018

Study Completion Date

October 31, 2018

Conditions
Critical Lower Limb IschemiaType-2 Diabetes Mellitus
Interventions
BIOLOGICAL

Group A: Intramuscular

"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."

BIOLOGICAL

Group B: Intraarterial

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

BIOLOGICAL

Group C: Intravenous

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

PROCEDURE

Group D: Surgical endovascular treatment with maximum medicamentous treatment

Group D: Control Group Control Group - no experimental intervention, standard endovascular treatment or bypass surgery or maximum medicamentous treatment

Trial Locations (1)

708 52

University Hospital Ostrava, Ostrava

All Listed Sponsors
collaborator

Ministry of Health, Czech Republic

OTHER_GOV

collaborator

Regional Council of the Moravian-Silesian region, KU MSK

UNKNOWN

lead

University Hospital Ostrava

OTHER

NCT01818310 - Safety and Efficacy Study of Autologous Bone Marrow Aspirate Concentrate for No-Option Critical Limb Ischemia | Biotech Hunter | Biotech Hunter