Clinical trial NCT02566655: Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Spinal Fractures
Lead sponsor: Red de Terapia Celular
Sponsor class: INDUSTRY
Collaborators: name: Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
name: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
name: Hospital Universitario Virgen de la Arrixaca
name: Spanish National Health System
name: Public Health Service, Murcia
name: BIONAND, Universidad de Málaga, IBIMA, Ciber-bbn
name: Grupo de Tecnología Sanitaria CIBER-BBN, Inst. Biomecánica de Valencia
First posted: 2015-10-02
Enrollment: 10
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

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

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.
* Patients who are pregnant or breast-feeding actively.
* Patients physically fertile, defined as all women physiologically capable of becoming pregnant, UNLESS they are using reliable methods of contraception.

Primary outcomes:
measure: Rate of serious and non-serious adverse events related to the procedure.
timeFrame: 24 months from baseline
Secondary outcomes:
measure: Number of new fractures
timeFrame: 24 months from baseline
measure: Pain, measured by Visual Analog Scale
timeFrame: 24 months from baseline
measure: Functionality, measured by Oswestry Disability Questionnaire
timeFrame: 24 months from baseline
measure: Quality of Life, measured by EuroQoL-5D test
timeFrame: 24 months from baseline
measure: Bone resorption, measured by biochemical index
timeFrame: 24 months from baseline
measure: Bone formation, measured by biochemical index
timeFrame: 24 months from baseline
measure: Bone formation, measured by biochemical index
timeFrame: 24 months from baseline
measure: Bone formation, measured by biochemical index
timeFrame: 24 months from baseline
measure: Bone metabolism, measured by biochemical index
timeFrame: 24 months from baseline
measure: Bone metabolism, measured by biochemical index
timeFrame: 24 months from baseline
measure: Bone Mineral Density , measured by dual energy x-ray absorptiometry (DXA)
timeFrame: 24 months from baseline
measure: Bone structure, measured by histomorphometric evaluation
timeFrame: baseline and 4 months from baseline
measure: Trabecular bone density measured by quantitative computed tomography of the radius
timeFrame: 24 months from baseline
Other outcomes:
Locations:
city: El Palmar
country: Spain
facility: Hospital Clínico Virgen de la Arrixaca
state: Murcia
Study officials:
affiliation: Hospital Universitario Virgen de la Arrixaca
name: Luis F Linares Ferrando, MD
role: PRINCIPAL_INVESTIGATOR
References: