Atrophic Nonunion of Fracture Clinical Trial
Official title:
A Phase IIa, Single Center, Prospective, Randomized, Parallel, Two-arms, Single-dose, Open-label With Blinded Assessor Pilot Clinical Trial to Assess ex Vivo Expanded Adult Autologous Mesenchymal Stromal Cells Fixed in Allogeneic Bone Tissue (XCEL-MT-OSTEO-ALPHA) in Non Hypertrophic Pseudoarthrosis of Long Bones
| Verified date | April 2021 |
| Source | Banc de Sang i Teixits |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac crest. XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and Tissue Bank of Catalonia). The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration up to consolidation of non-union fractures.
| Status | Completed |
| Enrollment | 19 |
| Est. completion date | December 20, 2019 |
| Est. primary completion date | March 5, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - 18 to 85 years of age (male and female) - Atrophic or hypotrophic metaphyseal-diaphyseal pseudarthrosis of long bones, confirmed radiographically. - Signed Informed Consent Form - The patient is able to understand the nature of the study Exclusion Criteria: - Suspicious of pseudarthrosis focus infection diagnosed by clinical inspection and blood analysis. - Positive serology for HIV (Anti-HIV I/II-Ac), Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ac) or Syphilis Lúes (TP-Ac). - Significant abnormal laboratory tests that contraindicates patient's participation in the study. - Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding - Smoker of more than 15 cigarettes a day - Congenital disorders of bones (hypophosphatemia), bone metabolic disorders associated to primary or secondary hypoparathyroidism. - Badly managed diabetes mellitus. - Patients diagnosed with peripheral arterial disorders - Previous therapeutic radiation (5 previous years) of the affected bone. - Neoplasia within the previous 5 years, or without remission - The patient is legally dependent - Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days - Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria - The patient does not accept to be followed-up for a period that could exceed the clinical trial length |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital ASEPEYO Sant Cugat | Sant Cugat | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Banc de Sang i Teixits | Hospital ASEPEYO Sant Cugat |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures | Hounsfield units quantification by tomography in both treatment arms | 12 month | |
| Secondary | Safety assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures | Safety will be assessed by collecting adverse events throughout the experimental phase which includes a follow-up of 12 month. | 12 month | |
| Secondary | Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures | Characteristics of the callus by tomography and Characteristics of the callus by standard x-ray in both treatment arms | 6 month | |
| Secondary | Efficacy assessment by quality of life test | Quality of life will be measured by EUROQOL-5D test | 12 month |