Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Femoral Neck Fracture
• Intervention / Treatment: Drug: XCEL-MT-OSTEO-BETA; Procedure: Surgical treatment

Detailed 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).

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XCEL-MT-OSTEO-BETA; Adult ex-vivo expanded mesenchymal stromal cells from allogeneic bone marrow, cryopreserved, to combine with fibrin glue and cancellous human bone tissue + endomedullary nailing	Drug: XCEL-MT-OSTEO-BETA; XCEL-MT-OSTEO-BETA followed by endomedullary nailing; Procedure: Surgical treatment; Isolated endomedullary nailing
Other: Standard treatment; Standard surgical treatment with isolated endomedullary nailing	Procedure: Surgical treatment; Isolated endomedullary nailing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy through CT scan	assessment of consolidation by determination of Hounsfield units in CT scan	3 months
efficacy through xRay	assessment of bone callus characteristics by standard radiology	1, 3 and 6 months
efficacy by clinical assessment	Clinical assessment by visual analogue scale for pain	1, 3 and 6 month
efficacy by quality of life questionnaire	EUROQoL-5D quality of life questionnaire	3, 6 and 12 month

Collaborators and Investigators

• Sponsor: Banc de Sang i Teixits
• Collaborators: Fundacion Clinic per a la Recerca Biomédica
• Investigators: Principal Investigator: Josep Maria Segur, MD, PhD, Hospital Clinic of Barcelona

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 15, 2015

Study Record Updates

• Last Update Posted (Actual): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: elderly; stem cells; bone marrow; fracture; mesenchymal stromal cells; allogeneic; bone regeneration
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: XCEL-MT-10-03; 2010-024041-78 (EudraCT Number)