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Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis (CSM/OP/2011)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02566655
Recruitment Status : Active, not recruiting
First Posted : October 2, 2015
Last Update Posted : January 13, 2020
Sponsor:
Collaborators:
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Hospital Universitario Virgen de la Arrixaca
Spanish National Health System
Public Health Service, Murcia
BIONAND, Universidad de Málaga, IBIMA, Ciber-bbn
Grupo de Tecnología Sanitaria CIBER-BBN, Inst. Biomecánica de Valencia
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Spinal Fractures Biological: Fucosylated MSC for Osteoporosis Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 2018
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
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.





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Spain
Hospital Clínico Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Sponsors and Collaborators
Red de Terapia Celular
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Hospital Universitario Virgen de la Arrixaca
Spanish National Health System
Public Health Service, Murcia
BIONAND, Universidad de Málaga, IBIMA, Ciber-bbn
Grupo de Tecnología Sanitaria CIBER-BBN, Inst. Biomecánica de Valencia
Investigators
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Principal Investigator: Luis F Linares Ferrando, MD Hospital Universitario Virgen de la Arrixaca

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Responsible Party: Red de Terapia Celular
ClinicalTrials.gov Identifier: NCT02566655    
Other Study ID Numbers: CSM/OP/2011
2012-005814-20 ( EudraCT Number )
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: November 2019
Additional relevant MeSH terms:
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Osteoporosis
Spinal Fractures
Fractures, Bone
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Spinal Injuries
Back Injuries