Trials / Completed
CompletedNCT02230514
Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Banc de Sang i Teixits · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XCEL-MT-OSTEO-ALPHA | "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue in association with open surgery |
| OTHER | autologous iliac crest | Autologous iliac crest in association with surgery |
| PROCEDURE | Surgery | Standard surgery for non-union fractures |
Timeline
- Start date
- 2014-11-20
- Primary completion
- 2019-03-05
- Completion
- 2019-12-20
- First posted
- 2014-09-03
- Last updated
- 2021-04-12
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT02230514. Inclusion in this directory is not an endorsement.