Safety and Efficacy of Allogeneic Adipose Tissue Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia

PHASE2CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

January 11, 2021

Primary Completion Date

May 27, 2024

Study Completion Date

December 5, 2024

Conditions
Limb IschemiaDiabetic Foot
Interventions
DRUG

High dose allogeneic mesenchymal stromal cells

Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly

DRUG

Low dose allogeneic mesenchymal stromal cells

Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly

DRUG

Placebos

0,9% physiological saline

Trial Locations (10)

Unknown

Hospital General de Alicante, Alicante

Hospital Gregorio Marañon, Madrid

Hospital Universitario Fundacion Jimenez Diaz, Madrid

La Paz University Hospital, Madrid

Hospital Clinico Universitario Virgen de la Arrixaca, Murcia

Clinica Universidad de Navarra, Pamplona

Hospital Universitario de Salamanca, Salamanca

Hospital Victoria Eugenia Cruz Roja Española, Seville

Hospital Universitario La Fe, Valencia

Hospital de Valladolid, Valladolid

All Listed Sponsors
collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

collaborator

Hospital Universitario La Paz

OTHER

collaborator

Gregorio Marañón Hospital

OTHER

collaborator

Hospital Clínico Universitario de Valladolid

OTHER

collaborator

Hospital Universitario Virgen de la Arrixaca

OTHER

collaborator

University of Salamanca

OTHER

collaborator

Hospital General Universitario de Alicante

OTHER

collaborator

Hospital Universitario La Fe

OTHER

collaborator

Hospital Victoria Eugenia Cruz Roja Española

UNKNOWN

lead

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

OTHER

NCT04466007 - Safety and Efficacy of Allogeneic Adipose Tissue Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia | Biotech Hunter | Biotech Hunter