Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis (CSM/OP/2011)
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|ClinicalTrials.gov Identifier: NCT02566655|
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Spinal Fractures||Biological: Fucosylated MSC for Osteoporosis||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Clinical Trial To Evaluate The Intravenous Infusion Of Autologous Fucosylated Bone Marrow Mesenchymal Cells Therapy In Patients With Established Osteoporosis and Low Impact Fractures|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||May 2018|
Experimental: Fucosylated MSC for Osteoporosis
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.
Biological: Fucosylated 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.
- Rate of serious and non-serious adverse events related to the procedure. [ Time Frame: 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.
- Number of new fractures [ Time Frame: 24 months from baseline ]
- Pain, measured by Visual Analog Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 24 months from baseline ]To measure the quality of life EuroQoL-5D psychometric test is used.
- Bone resorption, measured by biochemical index [ Time Frame: 24 months from baseline ]Aminoterminal telopeptide of type 1 collagen in the serum (serum NTX) (%) by ELISA technique.
- Bone formation, measured by biochemical index [ Time Frame: 24 months from baseline ]Osteocalcin in the serum by ELISA (BPG serum) (ng / mL) .
- Bone formation, measured by biochemical index [ Time Frame: 24 months from baseline ]Bone specific alkaline phosphatase in the serum by ELISA (serum FAO) (ug / L)
- Bone formation, measured by biochemical index [ Time Frame: 24 months from baseline ]Aminoterminal propeptide of procollagen type 1 in the serum by ELISA (serum P1NP) (ng / mL)
- Bone metabolism, measured by biochemical index [ Time Frame: 24 months from baseline ]Osteoprotegerin (OPG) (pmol / L) in the serum by ELISA.
- Bone metabolism, measured by biochemical index [ Time Frame: 24 months from baseline ]Ligand receptor activator of nuclear factor KB (RANKL) (pmol / L) in the serum by ELISA.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566655
|Hospital Clínico Virgen de la Arrixaca|
|El Palmar, Murcia, Spain, 30120|
|Principal Investigator:||Luis F Linares Ferrando, MD||Hospital Universitario Virgen de la Arrixaca|