Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis
CSM/OP/2011
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
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedOctober 8, 2020
November 1, 2019
1.3 years
January 30, 2015
October 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (13)
Number of new fractures
24 months from baseline
Pain, measured by Visual Analog Scale
24 months from baseline
Functionality, measured by Oswestry Disability Questionnaire
24 months from baseline
Quality of Life, measured by EuroQoL-5D test
24 months from baseline
Bone resorption, measured by biochemical index
24 months from baseline
- +8 more secondary outcomes
Study Arms (1)
Fucosylated MSC for Osteoporosis
EXPERIMENTALAutologous 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with established osteoporosis according to standard clinical criteria.
- Patients who give their written informed consent to participate in the study consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Red de Terapia Celularlead
- Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixacacollaborator
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murciacollaborator
- Hospital Universitario Virgen de la Arrixacacollaborator
- Spanish National Health Systemcollaborator
- Public Health Service, Murciacollaborator
- BIONAND, Universidad de Málaga, IBIMA, Ciber-bbncollaborator
- Grupo de Tecnología Sanitaria CIBER-BBN, Inst. Biomecánica de Valenciacollaborator
Study Sites (1)
Hospital Clínico Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis F Linares Ferrando, MD
Hospital Universitario Virgen de la Arrixaca
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2015
First Posted
October 2, 2015
Study Start
September 1, 2015
Primary Completion
December 1, 2016
Study Completion
May 1, 2018
Last Updated
October 8, 2020
Record last verified: 2019-11