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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005814-20 | EudraCT Number |
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| Name | Class |
|---|---|
| Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca | OTHER |
| Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | OTHER |
| Hospital Universitario Virgen de la Arrixaca |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fucosylated MSC for Osteoporosis | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fucosylated MSC for Osteoporosis | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of new fractures | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis F Linares Ferrando, MD | Hospital Universitario Virgen de la Arrixaca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| Spanish National Health System | OTHER |
| Public Health Service, Murcia | OTHER |
| BIONAND, Universidad de Málaga, IBIMA, Ciber-bbn | UNKNOWN |
| Grupo de Tecnología Sanitaria CIBER-BBN, Inst. Biomecánica de Valencia | UNKNOWN |
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| 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. | 24 months from baseline |
| Quality of Life, measured by EuroQoL-5D test | To measure the quality of life EuroQoL-5D psychometric test is used. | 24 months from baseline |
| Bone resorption, measured by biochemical index | Aminoterminal telopeptide of type 1 collagen in the serum (serum NTX) (%) by ELISA technique. | 24 months from baseline |
| Bone formation, measured by biochemical index | Osteocalcin in the serum by ELISA (BPG serum) (ng / mL) . | 24 months from baseline |
| Bone formation, measured by biochemical index | Bone specific alkaline phosphatase in the serum by ELISA (serum FAO) (ug / L) | 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) | 24 months from baseline |
| Bone metabolism, measured by biochemical index | Osteoprotegerin (OPG) (pmol / L) in the serum by ELISA. | 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. | 24 months from baseline |
| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |