CompletedNCT02483364BonecureUpdated Mar 17, 2021

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 interventional study of HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment) in Pseudoarthrosis, sponsored by Salvat. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-17.

Sponsored by Salvat · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 12
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Pseudoarthrosis

Browse trials for

Pseudarthrosis 41

In context

Pseudarthrosis

41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.

This study's enrollment of 12 is below the median of 22 across 25 interventional studies indexed under Pseudarthrosis.

Browse Pseudarthrosis studies →

Lead sponsor

Salvat is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients of either sex between 18 and 65 years of age (both inclusive).
Diagnosis of atrophic pseudoarthrosis of long bones confirmed radiographically.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 12 participants (actual)

Study arms

Experimental
Experimental
HC-SVT-1001. Intraosseous use. 3x10(6) cells/cm3. (Initial protocol) HC-SVT-1002. Intraosseous use. 3x10(6) cells/cm3. (Protocol amendment)
Other: HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)

Interventions

OtherHC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)
A single application in the context of a single surgical intervention.

What researchers measure

Primary outcomes

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.

Secondary outcomes

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.
Time frame: Up to 24 months after surgery.

Study locations

1 site

Laboratorios Salvat, S.A.
Esplugues de Llobregat, Barcelone 08950, Spain

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2015 to primary completion in May 2020, 54 months.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 15, 2015
First posted: Jun 26, 2015
StartActual: Nov 10, 2015
Primary completionActual: May 18, 2020
CompletionActual: Oct 20, 2020
Last update: Mar 17, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02483364
Lead sponsor: Salvat
Responsible party: Sponsor
First posted: Jun 26, 2015
Start date: Nov 10, 2015
Primary completion: May 18, 2020
Completion: Oct 20, 2020
Last update: Mar 17, 2021

Study contacts

Enrique Jimenez, MD

study chair · Laboratorios Salvat

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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