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)

NCT02483364 | Completed Phase 2 DMC

• 1 other identifier: STEMQUIRI/12ES01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudoarthrosis

Outcome Measures

Primary Outcomes (2)

• 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.

• Effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation.

  Within 6 months after surgery.

Secondary Outcomes (1)

• Comparative statistical analysis

  Up to 24 months after surgery.

Study Arms (1)

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

HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment) OTHER

A single application in the context of a single surgical intervention.

Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Present infection (infection signs should not be evidenced).
• Other lesions which interfere with the body weight load.
• 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.

Sponsors & Collaborators

• Salvat: lead

Study Sites (1)

Laboratorios Salvat, S.A.

Esplugues de Llobregat, Barcelone, 08950, Spain

Location

Related Publications (1)

• 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.

  PMID: 38789992 DERIVED

MeSH Terms

Conditions

Pseudarthrosis

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Fractures, Ununited; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Enrique Jimenez, MD

  Laboratorios Salvat

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cell therapy

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: June 26, 2015
• Study Start: November 10, 2015
• Primary Completion: May 18, 2020
• Study Completion: October 20, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

ES (1)