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Trial record 8 of 35 for:    terapia celular

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 : Completed
First Posted : October 2, 2015
Last Update Posted : October 8, 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

Tracking Information
First Submitted Date  ICMJE January 30, 2015
First Posted Date  ICMJE October 2, 2015
Last Update Posted Date October 8, 2020
Study Start Date  ICMJE September 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • Number of new fractures [ Time Frame: 24 months from baseline ]
  • 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.
  • 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.
  • 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.
  • 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.
  • Bone formation, measured by biochemical index [ Time Frame: 24 months from baseline ]
    Osteocalcin in the serum by ELISA (BPG serum) (ng / mL) .
  • 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)
  • 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)
  • Bone metabolism, measured by biochemical index [ Time Frame: 24 months from baseline ]
    Osteoprotegerin (OPG) (pmol / L) in the serum by ELISA.
  • 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.
  • Bone Mineral Density , measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: 24 months from baseline ]
  • Bone structure, measured by histomorphometric evaluation [ Time Frame: baseline and 4 months from baseline ]
  • Trabecular bone density measured by quantitative computed tomography of the radius [ Time Frame: 24 months from baseline ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
  • Number of new fractures [ Time Frame: 24 months from baseline ]
  • Pain, as 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.
  • Functionality, as 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.
  • Quality of Life, as measured by EuroQoL-5D test [ Time Frame: 24 months from baseline ]
    To measure the quality of life EuroQoL-5D psychometric test is used.
  • 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.
  • Bone formation, measured by biochemical index [ Time Frame: 24 months from baseline ]
    Osteocalcin in the serum by ELISA (BPG serum) (ng / mL) .
  • 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)
  • 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)
  • Bone metabolism, measured by biochemical index [ Time Frame: 24 months from baseline ]
    Osteoprotegerin (OPG) (pmol / L) in the serum by ELISA.
  • 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.
  • Bone Mineral Density , measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: 24 months from baseline ]
  • Bone structure, measured by histomorphometric evaluation [ Time Frame: 24 months from baseline ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Spinal Fractures
Intervention  ICMJE 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.

Study Arms  ICMJE 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.
Intervention: Biological: Fucosylated MSC for Osteoporosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 30, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02566655
Other Study ID Numbers  ICMJE CSM/OP/2011
2012-005814-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Red de Terapia Celular
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Red de Terapia Celular
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Luis F Linares Ferrando, MD Hospital Universitario Virgen de la Arrixaca
PRS Account Red de Terapia Celular
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP