Osteoporosis, Spinal Fractures
Conditions
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.
Interventions
BIOLOGICALFucosylated 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
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Hospital Universitario Virgen de la Arrixaca
Spanish National Health System
Public Health Service, Murcia
BIONAND, Universidad de Málaga, IBIMA, Ciber-bbn
Grupo de Tecnología Sanitaria CIBER-BBN, Inst. Biomecánica de Valencia
Red de Terapia Celular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of serious and non-serious adverse events related to the procedure. | 24 months from baseline | During time frame the following items will be considered: Adverse effects related to the infusion moment. Occurrence of infectious complications after infusion of mesenchymal stem cells, because of the immunosuppressive effect of these cells. Appearance of procedure-related neoplasias. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain, measured by Visual Analog Scale | 24 months from baseline | To measure pain, visual analogue scale (VAS) was used where 0 is no pain and 10 the worst pain imaginable. |
| Functionality, measured by Oswestry Disability Questionnaire | 24 months from baseline | To identify the functional repercussion of lumbar pain, Oswestry Disability Questionnaire for back pain or Oswestry Disability Index is used. |
| Quality of Life, measured by EuroQoL-5D test | 24 months from baseline | To measure the quality of life EuroQoL-5D psychometric test is used. |
| Bone resorption, measured by biochemical index | 24 months from baseline | Aminoterminal telopeptide of type 1 collagen in the serum (serum NTX) (%) by ELISA technique. |
| Number of new fractures | 24 months from baseline | — |
| Bone metabolism, measured by biochemical index | 24 months from baseline | Osteoprotegerin (OPG) (pmol / L) in the serum by ELISA. |
| Bone Mineral Density , measured by dual energy x-ray absorptiometry (DXA) | 24 months from baseline | — |
| Bone structure, measured by histomorphometric evaluation | baseline and 4 months from baseline | — |
| Trabecular bone density measured by quantitative computed tomography of the radius | 24 months from baseline | — |
| Bone formation, measured by biochemical index | 24 months from baseline | Osteocalcin in the serum by ELISA (BPG serum) (ng / mL) . |
Countries
Spain
Outcome results
None listed