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) (Bonecure)
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ClinicalTrials.gov Identifier: NCT02483364 |
Recruitment Status :
Completed
First Posted : June 26, 2015
Last Update Posted : March 17, 2021
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Condition or disease | Intervention/treatment | Phase |
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Pseudoarthrosis | Other: HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Cell therapy |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 10, 2015 |
Actual Primary Completion Date : | May 18, 2020 |
Actual Study Completion Date : | October 20, 2020 |
Arm | Intervention/treatment |
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Experimental: Experimental
HC-SVT-1001. Intraosseous use. 3x10(6) cells/cm3. (Initial protocol) HC-SVT-1002. Intraosseous use. 3x10(6) cells/cm3. (Protocol amendment)
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Other: HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)
A single application in the context of a single surgical intervention. |
- 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. ]
- Comparative statistical analysis [ Time Frame: Up to 24 months after surgery. ]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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483364
Spain | |
Laboratorios Salvat, S.A. | |
Esplugues de Llobregat, Barcelone, Spain, 08950 |
Study Chair: | Enrique Jimenez, MD | Laboratorios Salvat |
Responsible Party: | Salvat |
ClinicalTrials.gov Identifier: | NCT02483364 |
Other Study ID Numbers: |
STEMQUIRI/12ES01 |
First Posted: | June 26, 2015 Key Record Dates |
Last Update Posted: | March 17, 2021 |
Last Verified: | March 2021 |
Pseudarthrosis Fractures, Ununited Fractures, Bone Wounds and Injuries |