Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

December 31, 2016

Study Completion Date

May 31, 2018

Conditions
OsteoporosisSpinal Fractures
Interventions
BIOLOGICAL

Fucosylated MSC for Osteoporosis

"Aproximately 30 days before the infusion of the investigational product, patient bone marrow will be obtained according to standard practice of the Haematology University Hospital Virgen de la Arrixaca (HCUVA).~Mononuclear bone marrow cells will be separated and cultured in GMP conditions to purify and obtain mesenchymal cell established dose range. The infusion day BM-MSCs will be fucosylated and resuspended in saline to a concentration of 5 million cells per 1 mL. Then, the final product will be packaged in syringes for intravenous administration to patients through a peripheral venous access."

Trial Locations (1)

30120

Hospital Clínico Virgen de la Arrixaca, El Palmar

All Listed Sponsors
collaborator

Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

OTHER

collaborator

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

OTHER

collaborator

Hospital Universitario Virgen de la Arrixaca

OTHER

collaborator

Spanish National Health System

OTHER

collaborator

Public Health Service, Murcia

OTHER

collaborator

BIONAND, Universidad de Málaga, IBIMA, Ciber-bbn

UNKNOWN

collaborator

Grupo de Tecnología Sanitaria CIBER-BBN, Inst. Biomecánica de Valencia

UNKNOWN

lead

Red de Terapia Celular

INDUSTRY

NCT02566655 - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis | Biotech Hunter | Biotech Hunter