Clinical trial: Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis (NCT02566655)

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.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Entailment