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)

Salvat

Status and phase: Completed; Phase 2

Conditions: Pseudoarthrosis

Treatments: Other: HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02483364

STEMQUIRI/12ES01

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Experimental

Experimental group

Description:

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

Treatment:

Other: HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)