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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | HC-SVT-1001. Intraosseous use. 3x10(6) cells/cm3. (Initial protocol) HC-SVT-1002. Intraosseous use. 3x10(6) cells/cm3. (Protocol amendment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment) | Other | A single application in the context of a single surgical intervention. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrique Jimenez, MD | Laboratorios Salvat | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorios Salvat, S.A. | Esplugues de Llobregat | Barcelone | 08950 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38789992 | Derived | 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. |
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Cell therapy
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| ID | Term |
|---|---|
| D011542 | Pseudarthrosis |
| ID | Term |
|---|---|
| D005599 | Fractures, Ununited |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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