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)

March 16, 2021 updated by: Salvat

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.
Within 6 months after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salvat

Investigators

  • Study Chair: Enrique Jimenez, MD, Laboratorios SALVAT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2015

Primary Completion (Actual)

May 18, 2020

Study Completion (Actual)

October 20, 2020

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEMQUIRI/12ES01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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