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Completed

NCT Number: NCT02566655

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

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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Key information

Conditions

Osteoporosis Back Injuries Bone Diseases Bone Diseases, Metabolic Fractures, Bone Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Spinal Fractures Spinal Injuries Wounds and Injuries

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Clínico Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of new fractures

    Time frame: 24 months from baseline

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Bone formation, measured by biochemical index

    Time frame: 24 months from baseline

    Osteocalcin in the serum by ELISA (BPG serum) (ng / mL) .

  7. 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)

  8. 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)

  9. Bone metabolism, measured by biochemical index

    Time frame: 24 months from baseline

    Osteoprotegerin (OPG) (pmol / L) in the serum by ELISA.

  10. 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.

  11. Bone Mineral Density , measured by dual energy x-ray absorptiometry (DXA)

    Time frame: 24 months from baseline

  12. Bone structure, measured by histomorphometric evaluation

    Time frame: baseline and 4 months from baseline

  13. Trabecular bone density measured by quantitative computed tomography of the radius

    Time frame: 24 months from baseline

Sponsors and collaborators

Lead sponsor

Red de Terapia Celular

Industry

Collaborators

  • BIONAND, Universidad de Málaga, IBIMA, Ciber-bbn
  • Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
  • Grupo de Tecnología Sanitaria CIBER-BBN, Inst. Biomecánica de Valencia
  • Hospital Universitario Virgen de la Arrixaca
  • Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
  • Public Health Service, Murcia
  • Spanish National Health System

Registry information

Official study 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

Acronym: CSM/OP/2011

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Oct 2, 2015
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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