PseudoarthrosisPhase 2BonecureNCT02483364
A Clinical Trial to Assess the Effect of HC-SVT-1001 and HC-SVT-1002 in the Surgical Treatment of Atrophic Pseudarthrosis of Long Bones (Bonecure)
A Phase 2 study testing HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment) in people with Pseudoarthrosis, run by Salvat at 1 site in Spain.
Trial summary
The purpose os this study is to evaluate the safety and effectiveness of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pseudoarthrosis
- What is being tested?
- HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 10 Nov 2015to 20 Oct 2020
- Phase
- Phase 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
- Patients of either sex between 18 and 65 years of age (both inclusive).
- Diagnosis of atrophic pseudoarthrosis of long bones confirmed radiographically.
Who cannot join
- Present infection (infection signs should not be evidenced).
- Other lesions which interfere with the body weight load.
- Open pseudoarthrosis (at the time of inclusion).
- Congenital bone diseases (hypophosphatemia), metabolic bone disease associated with primary or secondary hypoparathyroidism.
- Other conditions or circumstances that compromise the study participation according to medical criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Clinical Trial to Assess the Effect of HC-SVT-1001 (Autologous Fat Stem Adult Mesenchymal Cells Expanded and Combined With a Tricalcium Phosphate Biomaterial) and HC-SVT-1002 (Allogeneic Fat Stem Adult Mesenchymal Cells Expanded and Combined With a Tricalcium Phosphate Biomaterial) in the Surgical Treatment of Atrophic Pseudarthrosis of Long Bones
The purpose os this study is to evaluate the safety and effectiveness of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones.
- Conditions
- Pseudoarthrosis
- Being tested
- HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)
- Medical subject headings
- Pseudarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)Other
A single application in the context of a single surgical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | HC-SVT-1001. Intraosseous use. 3x10(6) cells/cm3. (Initial protocol) HC-SVT-1002. Intraosseous use. 3x10(6) cells/cm3. (Protocol amendment) Receives: Other: HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events.
Measured: Up to 24 months after surgery.
Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation.
Measured: Within 6 months after surgery.
Secondary outcomes (1)
Comparative statistical analysis
Comparative statistical analysis between the 12 patients of this study and the data of 14 consecutive cases of refractory nonunion of long bones that have been treated since Sept-2009 with 40x10(6) autologous fat stem adult mesenchymal and under AEMPS compassionate use requirements.
Measured: Up to 24 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start10 Nov 2015
- Primary completion18 May 2020
- Study completion20 Oct 2020
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 PseudoarthrosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cell therapy
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salvat
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enrique Jimenez, MD, Study chair, Laboratorios Salvat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483364
- Sponsor's protocol ID
- STEMQUIRI/12ES01
- Acronym
- Bonecure
- Status last verified
- Mar 2021
- First submitted
- 15 Apr 2015
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Orozco Delclos L, Soler Rich R, Arriaza Loureda R, Moreno Garcia A, Gomez Barrena E. Efficacy and safety of autologous or allogeneic mesenchymal stromal cells from adult adipose tissue expanded and combined with tricalcium phosphate biomaterial for the surgical treatment of atrophic nonunion of long bones: a phase II clinical trial. J Transl Med. 2024 May 24;22(1):493. doi: 10.1186/s12967-024-05280-x.
PubMed 38789992
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial to Assess the Effect of HC-SVT-1001 (Autologous Fat Stem Adult Mesenchymal Cells Expanded and Combined With a Tricalcium Phosphate Biomaterial) and HC-SVT-1002 (Allogeneic Fat Stem Adult Mesenchymal Cells Expanded and Combined With a Tricalcium Phosphate Biomaterial) in the Surgical Treatment of Atrophic Pseudarthrosis of Long Bones
- ClinicalTrials.gov ID
- NCT02483364
- Acronym / sponsor ID
- Bonecure / STEMQUIRI/12ES01
- Conditions
- Pseudoarthrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- SalvatIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2015 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 26 Jun 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 os this study is to evaluate the safety and effectiveness of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cell therapy
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)HC-SVT-1001. Intraosseous use. 3x10(6) cells/cm3. (Initial protocol) HC-SVT-1002. Intraosseous use. 3x10(6) cells/cm3. (Protocol amendment) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of either sex between 18 and 65 years of age (both inclusive).
- Diagnosis of atrophic pseudoarthrosis of long bones confirmed radiographically.
Key exclusion criteria (5 listed)
- Present infection (infection signs should not be evidenced).
- Other lesions which interfere with the body weight load.
- Open pseudoarthrosis (at the time of inclusion).
- Congenital bone diseases (hypophosphatemia), metabolic bone disease associated with primary or secondary hypoparathyroidism.
- Other conditions or circumstances that compromise the study participation according to medical criteria.
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 |
|---|---|---|
| HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)A single application in the context of a single surgical intervention. | Other | Experimental |
Primary outcome
Safety of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events.
Time frame: Up to 24 months after surgery.
Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation.
Time frame: Within 6 months after surgery.
1 secondary outcome
Comparative statistical analysis
Time frame: Up to 24 months after surgery.
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 17 Mar 2021.
- Derived from this study: PubMed 38789992Orozco Delclos L, Soler Rich R, Arriaza Loureda R, Moreno Garcia A, Gomez Barrena E. Efficacy and safety of autologous or allogeneic mesenchymal stromal cells from adult adipose tissue expanded and combined with tricalcium phosphate biomaterial for the surgical treatment of atrophic nonunion of long bones: a phase II clinical trial. J Transl Med. 2024 May 24;22(1):493. doi: 10.1186/s12967-024-05280-x.
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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.
Enrique Jimenez, MD study chair
Laboratorios Salvat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment) in people with Pseudoarthrosis, run by Salvat 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 2 inclusion and 5 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 17 Mar 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 phase mean?
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?
Safety of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events. (time frame: Up to 24 months after surgery.). The study lists 2 primary outcomes in all. 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 NCT02483364, 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 17 Mar 2021.