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

NCT02566655 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-10-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of intravenous infusion of fucosylated autologous bone marrow cells as a new therapy in patients with established osteoporosis by a prospective, single-center, open, non-randomized and unblinded clinical trial.

Conditions

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.

Sponsors & Collaborators

  • Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

    collaborator OTHER

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

    collaborator OTHER

  • Hospital Universitario Virgen de la Arrixaca

    collaborator OTHER

  • Spanish National Health System

    collaborator OTHER

  • Public Health Service, Murcia

    collaborator OTHER

  • BIONAND, Universidad de Málaga, IBIMA, Ciber-bbn

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • Red de Terapia Celular

    lead INDUSTRY

Principal Investigators

  • Luis F Linares Ferrando, MD · Hospital Universitario Virgen de la Arrixaca

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-12-31
Completion
2018-05-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02566655 on ClinicalTrials.gov