OsteoporosisPhase 1CSM/OP/2011NCT02566655
Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis
A Phase 1 study testing Fucosylated MSC for Osteoporosis in people with Osteoporosis and Spinal Fractures, run by Red de Terapia Celular at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Osteoporosis, Spinal Fractures
- What is being tested?
- Fucosylated MSC for Osteoporosis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Osteoporosis, Spinal Fractures
- Being tested
- Fucosylated MSC for Osteoporosis
- Medical subject headings
- Osteoporosis, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fucosylated MSC for OsteoporosisBiological
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 group | Role | What they receive |
|---|---|---|
| Fucosylated MSC for Osteoporosis | Experimental | 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. Receives: Biological: Fucosylated MSC for Osteoporosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of serious and non-serious adverse events related to the procedure.
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.
Measured: 24 months from baseline
Secondary outcomes (13)
Number of new fractures
Measured: 24 months from baseline
Pain, measured by Visual Analog Scale
To measure pain, visual analogue scale (VAS) was used where 0 is no pain and 10 the worst pain imaginable.
Measured: 24 months from baseline
Functionality, measured by Oswestry Disability Questionnaire
To identify the functional repercussion of lumbar pain, Oswestry Disability Questionnaire for back pain or Oswestry Disability Index is used.
Measured: 24 months from baseline
Quality of Life, measured by EuroQoL-5D test
To measure the quality of life EuroQoL-5D psychometric test is used.
Measured: 24 months from baseline
Bone resorption, measured by biochemical index
Aminoterminal telopeptide of type 1 collagen in the serum (serum NTX) (%) by ELISA technique.
Measured: 24 months from baseline
Bone formation, measured by biochemical index
Osteocalcin in the serum by ELISA (BPG serum) (ng / mL) .
Measured: 24 months from baseline
Bone formation, measured by biochemical index
Bone specific alkaline phosphatase in the serum by ELISA (serum FAO) (ug / L)
Measured: 24 months from baseline
Bone formation, measured by biochemical index
Aminoterminal propeptide of procollagen type 1 in the serum by ELISA (serum P1NP) (ng / mL)
Measured: 24 months from baseline
Bone metabolism, measured by biochemical index
Osteoprotegerin (OPG) (pmol / L) in the serum by ELISA.
Measured: 24 months from baseline
Bone metabolism, measured by biochemical index
Ligand receptor activator of nuclear factor KB (RANKL) (pmol / L) in the serum by ELISA.
Measured: 24 months from baseline
Bone Mineral Density , measured by dual energy x-ray absorptiometry (DXA)
Measured: 24 months from baseline
Bone structure, measured by histomorphometric evaluation
Measured: baseline and 4 months from baseline
Trabecular bone density measured by quantitative computed tomography of the radius
Measured: 24 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Red de Terapia Celular
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Sponsor
- Investigators
- Luis F Linares Ferrando, MD, Principal investigator, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566655
- Sponsor's protocol ID
- CSM/OP/2011
- Other IDs
- 2012-005814-20
- Acronym
- CSM/OP/2011
- Status last verified
- Nov 2019
- First submitted
- 30 Jan 2015
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moraleda JM, Linares LF, Garcia-Bernal D, Lozano-Rivas N, Ruiz-Sara J, Blanquer M, Lopez-Lucas MD, Sanchez-Salinas D, Alguero MC, Molina-Molina MM, Ruiz-Espejo F, Peris-Serra JL, Arrabal PM, Becerra J, Kiwitt-Cardenas J, Marras C, Garcia-Hernandez AM, Sackstein R. Glycocalyx-edited mesenchymal stem/stromal cell therapy in advanced osteoporosis. Cell. 2026 Sep 11:S0092-8674(26)00944-X. doi: 10.1016/j.cell.2026.08.017. Online ahead of print.
PubMed 42727576
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02566655
- Acronym / sponsor ID
- CSM/OP/2011 / CSM/OP/2011
- Conditions
- Osteoporosis, Spinal Fractures
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Red de Terapia CelularIndustry (pharma, biotech, devices)
- 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
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fucosylated MSC for Osteoporosis | Experimental | Biological: Fucosylated MSC for OsteoporosisAutologous 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fucosylated MSC for OsteoporosisAproximately 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. | Biological | Fucosylated MSC for Osteoporosis |
Primary outcome
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.
13 secondary outcomes
Number of new fractures
Time frame: 24 months from baseline
Pain, measured by Visual Analog Scale
Time frame: 24 months from baseline
Functionality, measured by Oswestry Disability Questionnaire
Time frame: 24 months from baseline
Quality of Life, measured by EuroQoL-5D test
Time frame: 24 months from baseline
Bone resorption, measured by biochemical index
Time frame: 24 months from baseline
Bone formation, measured by biochemical index
Time frame: 24 months from baseline
Bone formation, measured by biochemical index
Time frame: 24 months from baseline
Bone formation, measured by biochemical index
Time frame: 24 months from baseline
Bone metabolism, measured by biochemical index
Time frame: 24 months from baseline
Bone metabolism, measured by biochemical index
Time frame: 24 months from baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 42727576Moraleda JM, Linares LF, Garcia-Bernal D, Lozano-Rivas N, Ruiz-Sara J, Blanquer M, Lopez-Lucas MD, Sanchez-Salinas D, Alguero MC, Molina-Molina MM, Ruiz-Espejo F, Peris-Serra JL, Arrabal PM, Becerra J, Kiwitt-Cardenas J, Marras C, Garcia-Hernandez AM, Sackstein R. Glycocalyx-edited mesenchymal stem/stromal cell therapy in advanced osteoporosis. Cell. 2026 Sep 11:S0092-8674(26)00944-X. doi: 10.1016/j.cell.2026.08.017. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis F Linares Ferrando, MD principal investigator
Hospital Universitario Virgen de la Arrixaca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fucosylated MSC for Osteoporosis in people with Osteoporosis and Spinal Fractures, run by Red de Terapia Celular at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of serious and non-serious adverse events related to the procedure. (time frame: 24 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02566655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.