Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture

Femoral Neck Fracture Clinical Trial

Official title:

A Pilot Clinical Trial of ex Vivo Expanded Allogenic Adult Stem Cells Combined With Allogenic Human Bone Tissue (XCEL-MT-OSTEO-BETA) in Proximal Femur Fractures in Elderly Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02630836
• Other study ID #: XCEL-MT-10-03
• Secondary ID: 2010-024041-78
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: December 10, 2015
• Last updated: March 16, 2017
• Start date: December 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Banc de Sang i Teixits
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor pilot study. Thirty-two (32) elderly patients with hip fracture will be randomized to one of the two treatment-arms (Xcel-MT-osteo-beta or Standard treatment) and be followed for 12 month with the primary objective of safety. Secondary objectives are efficacy through axial tomography and xRay, clinical efficacy and quality of life questionnaire.

Description:

Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor phase I-II pilot study.

Thirty-two (32) elderly patients (70-85 years of age) with type 31A2 y 31A3 fracture of the femur (AO/ASIF (Association for the Study of Internal Fixation) classification) admitted at the emergency room of the Hospital Clinic of Barcelona will be randomized 1:1 to one of the two treatment-arms (endomedullary nailing + XCEL-MT-OSTEO-BETA or isolated endomedullary nailing as the standard treatment). Once surgically treated, patients will be followed for 12 month with the primary objective of safety. Secondary objectives are efficacy through axial tomography and xRay, clinical efficacy and quality of life questionnaire (EUROQOL-5D).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patient between70 and 85 years old

2. Proximal femur fracture type 31A3 31a2 classification AO/ASIF.

3. Deambulation prior to fracture.

4. Written informed consent of the patient or family members.

Exclusion Criteria:

1. Presence of implants at proximal femur level.

2. Presence of local or systemic septic process.

3. Septic arthritis.

4. Dementia of any type.

5. Hematological and biochemical analysis with significant alterations that contraindicate surgery.

6. Patients with positive serology for HIV 1 and 2, Hepatitis B, Hepatitis C and syphilis.

7. Neoplastic disease detected in the last five years or without complete remission.

8. Immunosuppressive status.

9. Patients who received corticosteroids in the 3 months prior to study initiation.

10. Simultaneous participation in another clinical trial or treatment with another investigational product within 3 months prior to inclusion in the study.

11. Other conditions or circumstances that may compromise the patient's participation in the study according to medical criteria.

12. Patient refusal to be followed by a period that may exceed the clinical trial itself.

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone

Intervention

Drug:
• XCEL-MT-OSTEO-BETA
XCEL-MT-OSTEO-BETA followed by endomedullary nailing

Procedure:
• Surgical treatment
Isolated endomedullary nailing

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Banc de Sang i Teixits	Fundacion Clinic per a la Recerca Biomédica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety of XCEL-MT-OSTEO-BETA in proximal femur fractures by Adverse events, physical exam, laboratory tests.	Adverse events, physical exam, laboratory tests.	12 months
Secondary	efficacy through CT scan	assessment of consolidation by determination of Hounsfield units in CT scan	3 months
Secondary	efficacy through xRay	assessment of bone callus characteristics by standard radiology	1, 3 and 6 months
Secondary	efficacy by clinical assessment	Clinical assessment by visual analogue scale for pain	1, 3 and 6 month
Secondary	efficacy by quality of life questionnaire	EUROQoL-5D quality of life questionnaire	3, 6 and 12 month

External Links

•   Blood and Tissue Banc of Catalonia
•   Hospital Clínic de Barcelona
•   Hospital Clinic Foundation