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Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

Phase I Clinical Trial To Evaluate The Intravenous Infusion Of Autologous Fucosylated Bone Marrow Mesenchymal Cells Therapy In Patients With Established Osteoporosis and Low Impact Fractures

NCT02566655•Red de Terapia Celular

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Patients with established osteoporosis according to standard clinical criteria.
•Patients who give their written informed consent to participate in the study consent.

Exclusion Criteria

•Patients with concomitant systemic disease in the opinion of the investigator.
•Patients with rheumatoid arthritis, ankylosing spondylitis, chronic polyarticular arthritis.
•Current patients with neoplasm or history of any malignancy in the last 10 years except basal carcinoma or epidermoid skin.
•Patients with genetic disorders that are associated with secondary osteoporosis: Hemochromatosis, hypophosphatasia, osteogenesis imperfecta, Ehlers-Danlos syndrome, Marfan syndrome, Riley Day, porphyria, storage diseases syndrome.
•Patients receiving immunosuppressive chemotherapy or that could interfere with the process of cell proliferation.
•Transplant patients: bone marrow, kidney, liver, heart, lung.
•Patients with clinical criteria and anesthetics that contraindicate well sedation or bone marrow extraction.
•Patients participating in a clinical trial in the last 6 months.
•Patients with positive serology for hepatitis B, hepatitis C or HIV.
•Patients with inability to understand informed consent.
+2 more criteria

Locations (1)

Hospital Clínico Virgen de la Arrixaca

El Palmar, Murcia, Spain

Key Dates

Start Date

September 1, 2015

Primary Completion Date

December 1, 2016

Completion Date

May 1, 2018

Last Updated

October 8, 2020

Enrollment

ESTIMATED participants

Conditions

OsteoporosisSpinal Fractures

Interventions

Fucosylated MSC for Osteoporosis

BIOLOGICAL

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

NCT06731608

OsteoporosisLower Limb Fracture

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RECRUITING

Smart Wearable Device (gaitQ): Walk Better Project

NCT05913219

Parkinson DiseaseStroke+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Smart Wearable Device (gaitQ): Walk Better Project

Step-down Therapy After Long-term Osteoporosis Treatment

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