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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)

Sponsor
Salvat (Industry)
Overall Status
Completed
CT.gov ID
NCT02483364
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
59.3
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Cell therapyCell 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 :
Nov 10, 2015
Actual Primary Completion Date :
May 18, 2020
Actual Study Completion Date :
Oct 20, 2020

Arms and Interventions

Arm Intervention/Treatment
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)
A single application in the context of a single surgical intervention.

Outcome Measures

Primary Outcome Measures

  1. Safety of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events. [Up to 24 months after surgery.]

  2. Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation. [Within 6 months after surgery.]

Secondary Outcome Measures

  1. Comparative statistical analysis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Laboratorios Salvat, S.A. Esplugues de Llobregat Barcelone Spain 08950

Sponsors and Collaborators

  • Salvat

Investigators

  • Study Chair: Enrique Jimenez, MD, Laboratorios Salvat

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Salvat
ClinicalTrials.gov Identifier:
NCT02483364
Other Study ID Numbers:
  • STEMQUIRI/12ES01
First Posted:
Jun 26, 2015
Last Update Posted:
Mar 17, 2021
Last Verified:
Mar 1, 2021
Additional relevant MeSH terms:
Pseudarthrosis

Study Results

No Results Posted as of Mar 17, 2021