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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Hospital Clínico Virgen de la Arrixaca
El Palmar, Murcia, Spain
Rate of serious and non-serious adverse events related to the procedure.
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.
Time frame: 24 months from baseline
Number of new fractures
Time frame: 24 months from baseline
Pain, measured by Visual Analog Scale
To measure pain, visual analogue scale (VAS) was used where 0 is no pain and 10 the worst pain imaginable.
Time frame: 24 months from baseline
Functionality, measured by Oswestry Disability Questionnaire
To identify the functional repercussion of lumbar pain, Oswestry Disability Questionnaire for back pain or Oswestry Disability Index is used.
Time frame: 24 months from baseline
Quality of Life, measured by EuroQoL-5D test
To measure the quality of life EuroQoL-5D psychometric test is used.
Time frame: 24 months from baseline
Bone resorption, measured by biochemical index
Aminoterminal telopeptide of type 1 collagen in the serum (serum NTX) (%) by ELISA technique.
Time frame: 24 months from baseline
Bone formation, measured by biochemical index
Osteocalcin in the serum by ELISA (BPG serum) (ng / mL) .
Time frame: 24 months from baseline
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Bone formation, measured by biochemical index
Bone specific alkaline phosphatase in the serum by ELISA (serum FAO) (ug / L)
Time frame: 24 months from baseline
Bone formation, measured by biochemical index
Aminoterminal propeptide of procollagen type 1 in the serum by ELISA (serum P1NP) (ng / mL)
Time frame: 24 months from baseline
Bone metabolism, measured by biochemical index
Osteoprotegerin (OPG) (pmol / L) in the serum by ELISA.
Time frame: 24 months from baseline
Bone metabolism, measured by biochemical index
Ligand receptor activator of nuclear factor KB (RANKL) (pmol / L) in the serum by ELISA.
Time frame: 24 months from baseline
Bone Mineral Density , measured by dual energy x-ray absorptiometry (DXA)
Time frame: 24 months from baseline
Bone structure, measured by histomorphometric evaluation
Time frame: baseline and 4 months from baseline
Trabecular bone density measured by quantitative computed tomography of the radius
Time frame: 24 months from baseline