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)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pseudoarthrosis

Intervention / Treatment
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* Other: HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Cell therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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)<br>* A single application in the context of a single surgical intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative statistical analysis | 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. |