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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Banc de Sang i Teixits
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Radiologist will assess images in a blinded manner
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
XCEL-MT-OSTEO-ALPHA and surgery
"ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue
Intervention: XCEL-MT-OSTEO-ALPHA (Drug)
XCEL-MT-OSTEO-ALPHA and surgery
"ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue
Intervention: Surgery (Procedure)
Autologous iliac crest and surgery
Standard treatment
Intervention: autologous iliac crest (Other)
Autologous iliac crest and surgery
Standard treatment
Intervention: Surgery (Procedure)
Outcomes
Primary Outcomes
Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures
Time Frame: 12 month
Hounsfield units quantification by tomography in both treatment arms
Secondary Outcomes
- Efficacy assessment by quality of life test(12 month)
- Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures(6 month)
- Safety assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures(12 month)