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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Osteoporosis Spinal Fractures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fucosylated MSC for Osteoporosis

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients with established osteoporosis according to standard clinical criteria.
* Patients who give their written informed consent to participate in the study consent.

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No