Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis (CSM/OP/2011)

The Cellular Therapy Network (TerCel)

Status and phase: Completed; Phase 1

Conditions: Osteoporosis; Spinal Fractures

Treatments: Biological: Fucosylated MSC for Osteoporosis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02566655

2012-005814-20 (EudraCT Number)

CSM/OP/2011

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: No 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Fucosylated MSC for Osteoporosis

Experimental group

Description:

Autologous Bone Marrow fucosylated mesenchymal stem cells will be infused intravenously on Day 0. The first four patients enrolled will receive a single dose of 2 million cells/Kg and the last six patients enrolled, will receive a single dose of 5 million cells/kg.

Treatment:

Biological: Fucosylated MSC for Osteoporosis