Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture

NCT02630836 | Withdrawn Phase 1

• 2 other identifiers: XCEL-MT-10-032010-024041-78
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Femoral Neck Fracture

Keywords

mesenchymal stromal cells; stem cells; elderly; allogeneic; bone marrow; bone regeneration; fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• efficacy through CT scan

  3 months

• efficacy through xRay

  1, 3 and 6 months

• efficacy by clinical assessment

  1, 3 and 6 month

• efficacy by quality of life questionnaire

  3, 6 and 12 month

Study Arms (2)

XCEL-MT-OSTEO-BETA

EXPERIMENTAL

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; Procedure: Surgical treatment

Standard treatment

OTHER

Standard surgical treatment with isolated endomedullary nailing

Procedure: Surgical treatment

Interventions

XCEL-MT-OSTEO-BETA DRUG

XCEL-MT-OSTEO-BETA followed by endomedullary nailing

XCEL-MT-OSTEO-BETA

Surgical treatment PROCEDURE

Isolated endomedullary nailing

Standard treatment; XCEL-MT-OSTEO-BETA

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient between70 and 85 years old
• Proximal femur fracture type 31A3 31a2 classification AO/ASIF.
• Deambulation prior to fracture.
• Written informed consent of the patient or family members.

You may not qualify if:

• Presence of implants at proximal femur level.
• Presence of local or systemic septic process.
• Septic arthritis.
• Dementia of any type.
• Hematological and biochemical analysis with significant alterations that contraindicate surgery.
• Patients with positive serology for HIV 1 and 2, Hepatitis B, Hepatitis C and syphilis.
• Neoplastic disease detected in the last five years or without complete remission.
• Immunosuppressive status.
• Patients who received corticosteroids in the 3 months prior to study initiation.
• Other conditions or circumstances that may compromise the patient's participation in the study according to medical criteria.
• Patient refusal to be followed by a period that may exceed the clinical trial itself.

Sponsors & Collaborators

• Banc de Sang i Teixits: lead
• Fundacion Clinic per a la Recerca Biomédica: collaborator

Related Links

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

MeSH Terms

Conditions

Femoral Neck Fractures; Fractures, Bone

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Josep Maria Segur, MD, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 15, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 17, 2017

Record last verified: 2017-03