Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis

Phase 1

Completed

• Conditions: Osteoporosis; Spinal Fractures
• Interventions: Biological: Fucosylated MSC for Osteoporosis

• Registration Number: NCT02566655
• Lead Sponsor: Red de Terapia Celular

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-30
• Study Start: 2015-09
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-02
• Primary Completion: 2016-12
• Study Completion: 2018-05
• Status Verified: 2019-11
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fucosylated MSC for Osteoporosis	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
Bone structure, measured by histomorphometric evaluation	baseline and 4 months from baseline
Number of new fractures	24 months from baseline
Bone metabolism, measured by biochemical index	24 months from baseline	Ligand receptor activator of nuclear factor KB (RANKL) (pmol / L) in the serum by ELISA.
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	Aminoterminal propeptide of procollagen type 1 in the serum by ELISA (serum P1NP) (ng / mL)
Bone Mineral Density , measured by dual energy x-ray absorptiometry (DXA)	24 months from baseline
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.

Trial Locations

Locations (1)

Hospital Clínico Virgen de la Arrixaca; 🇪🇸 El Palmar, Murcia, Spain