Atrophic Nonunion of FracturePhase 1/2NCT02230514
Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones
A Phase 1/2 study testing XCEL-MT-OSTEO-ALPHA, autologous iliac crest and Surgery in people with Atrophic Nonunion of Fracture, run by Banc de Sang i Teixits at 1 site in Spain.
Trial summary
The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac crest. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atrophic Nonunion of Fracture
- What is being tested?
- XCEL-MT-OSTEO-ALPHA, autologous iliac crest and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- 20 Nov 2014to 20 Dec 2019
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 85 years of age (male and female)
- Atrophic or hypotrophic metaphyseal-diaphyseal pseudarthrosis of long bones, confirmed radiographically.
- Signed Informed Consent Form
- The patient is able to understand the nature of the study
Who cannot join
- Suspicious of pseudarthrosis focus infection diagnosed by clinical inspection and blood analysis.
- Positive serology for HIV (Anti-HIV I/II-Ac), Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ac) or Syphilis Lúes (TP-Ac).
- Significant abnormal laboratory tests that contraindicates patient's participation in the study.
- Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
- Smoker of more than 15 cigarettes a day
- Congenital disorders of bones (hypophosphatemia), bone metabolic disorders associated to primary or secondary hypoparathyroidism.
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- Badly managed diabetes mellitus.
- Patients diagnosed with peripheral arterial disorders
- Previous therapeutic radiation (5 previous years) of the affected bone.
- Neoplasia within the previous 5 years, or without remission
- The patient is legally dependent
- Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days
- Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
- The patient does not accept to be followed-up for a period that could exceed the clinical trial length
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIa, Single Center, Prospective, Randomized, Parallel, Two-arms, Single-dose, Open-label With Blinded Assessor Pilot Clinical Trial to Assess ex Vivo Expanded Adult Autologous Mesenchymal Stromal Cells Fixed in Allogeneic Bone Tissue (XCEL-MT-OSTEO-ALPHA) in Non Hypertrophic Pseudoarthrosis of Long Bones
The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac crest.
XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and Tissue Bank of Catalonia).
The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration up to consolidation of non-union fractures.
Read the detailed description
A phase IIa, single center, prospective, randomized, parallel, two-arms, single-dose, open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult autologous mesenchymal stromal cells fixed in allogeneic bone tissue (XCEL-MT-OSTEO-ALPHA) in non hypertrophic pseudoarthrosis of long bones.
- Conditions
- Atrophic Nonunion of Fracture
- Being tested
- XCEL-MT-OSTEO-ALPHA, autologous iliac crest, Surgery
- Keywords
- Nonunion fracture, Long bones, Pseudoarthrosis, Cell therapy, Tissue engineering, Mesenchymal stromal cells
- Medical subject headings
- Fractures, Ununited, Pseudarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XCEL-MT-OSTEO-ALPHADrug
"ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue in association with open surgery
autologous iliac crestOther
Autologous iliac crest in association with surgery
SurgeryProcedure or surgery
Standard surgery for non-union fractures
| Study group | Role | What they receive |
|---|---|---|
| XCEL-MT-OSTEO-ALPHA and surgery | Experimental | "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue Receives: Drug: XCEL-MT-OSTEO-ALPHA; Procedure: Surgery |
| Autologous iliac crest and surgery | Other | Standard treatment Receives: Other: autologous iliac crest; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures
Hounsfield units quantification by tomography in both treatment arms
Measured: 12 month
Secondary outcomes (3)
Safety assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures
Safety will be assessed by collecting adverse events throughout the experimental phase which includes a follow-up of 12 month.
Measured: 12 month
Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures
Characteristics of the callus by tomography and Characteristics of the callus by standard x-ray in both treatment arms
Measured: 6 month
Efficacy assessment by quality of life test
Quality of life will be measured by EUROQOL-5D test
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study start20 Nov 2014
- Primary completion5 Mar 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic Nonunion of FractureStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banc de Sang i Teixits
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital ASEPEYO Sant Cugat
- Responsible party
- Sponsor
- Investigators
- Fernando Granell, MD, PhD, Principal investigator, Hospital ASEPEYO Sant Cugat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230514
- Sponsor's protocol ID
- XCEL-PSART-01
- Other IDs
- 2013-005025-23
- Status last verified
- Apr 2021
- First submitted
- 17 Jul 2014
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Single Center, Prospective, Randomized, Parallel, Two-arms, Single-dose, Open-label With Blinded Assessor Pilot Clinical Trial to Assess ex Vivo Expanded Adult Autologous Mesenchymal Stromal Cells Fixed in Allogeneic Bone Tissue (XCEL-MT-OSTEO-ALPHA) in Non Hypertrophic Pseudoarthrosis of Long Bones
- ClinicalTrials.gov ID
- NCT02230514
- Acronym / sponsor ID
- XCEL-PSART-01
- Conditions
- Atrophic Nonunion of Fracture
- Keywords
- Nonunion fracture, Long bones, Pseudoarthrosis, Cell therapy, Tissue engineering, Mesenchymal stromal cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Banc de Sang i TeixitsUniversity, hospital or other
- Collaborators
- Hospital ASEPEYO Sant Cugat
- Study start
- 20 Nov 2014 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 3 Sep 2014 (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 present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac crest.
XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and Tissue Bank of Catalonia).
The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration up to consolidation of non-union fractures.
Detailed description
A phase IIa, single center, prospective, randomized, parallel, two-arms, single-dose, open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult autologous mesenchymal stromal cells fixed in allogeneic bone tissue (XCEL-MT-OSTEO-ALPHA) in non hypertrophic pseudoarthrosis of long bones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XCEL-MT-OSTEO-ALPHA and surgery | Experimental | Drug: XCEL-MT-OSTEO-ALPHA, Procedure: Surgery"ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue |
| Autologous iliac crest and surgery | Other | Other: autologous iliac crest, Procedure: SurgeryStandard treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 85 years of age (male and female)
- Atrophic or hypotrophic metaphyseal-diaphyseal pseudarthrosis of long bones, confirmed radiographically.
- Signed Informed Consent Form
- The patient is able to understand the nature of the study
Key exclusion criteria (14 listed)
- Suspicious of pseudarthrosis focus infection diagnosed by clinical inspection and blood analysis.
- Positive serology for HIV (Anti-HIV I/II-Ac), Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ac) or Syphilis Lúes (TP-Ac).
- Significant abnormal laboratory tests that contraindicates patient's participation in the study.
- Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
- Smoker of more than 15 cigarettes a day
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 |
|---|---|---|
| XCEL-MT-OSTEO-ALPHA"ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue in association with open surgery | Drug | XCEL-MT-OSTEO-ALPHA and surgery |
| autologous iliac crestAutologous iliac crest in association with surgery | Other | Autologous iliac crest and surgery |
| SurgeryStandard surgery for non-union fractures | Procedure or surgery | Autologous iliac crest and surgery, XCEL-MT-OSTEO-ALPHA and surgery |
Primary outcome
Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures
Time frame: 12 month
Hounsfield units quantification by tomography in both treatment arms
3 secondary outcomes
Safety assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures
Time frame: 12 month
Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures
Time frame: 6 month
Efficacy assessment by quality of life test
Time frame: 12 month
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 12 Apr 2021.
- Banc de Sang i Teixits (Blood and Tissue Bank of Catalonia)Link provided by the sponsor.
- Hospital ASEPEYO Sant CugatLink provided by the sponsor.
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.
Fernando Granell, MD, PhD principal investigator
Hospital ASEPEYO Sant Cugat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XCEL-MT-OSTEO-ALPHA, autologous iliac crest and Surgery in people with Atrophic Nonunion of Fracture, run by Banc de Sang i Teixits 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 4 inclusion and 14 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 12 Apr 2021. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2021.