Stem Cells and Tibial Fractures

Study Overview
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Brief Summary
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The aim of this trial is to determine the safety and tolerability of expanded autologous progeny of an adult CD34+ (haemopoietic) stem cell subset when infused directly into the tibial artery of patients with recent tibial fracture. The trial will also seek to determine clinical improvement or deterioration by measurement of clinical parameters such as, length of time to union of the fracture, changes in bone mineral density, improvements in pain scores (VAS), functional ability (TUGT) and IPAQ scores.

Official Title
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A Phase I Safety Study Following the Infusion of Expanded Autologous Progeny of an Adult CD34+ Stem Cell Subset to Patients With Recent Tibial Fractures

Conditions
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Tibial Fractures

Intervention / Treatment
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* Other: CD34+ haemopoietic stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed closed tibial fracture on one limb only Normal blood count Normal coagulation screen Life expectancy of at least 12 months Ability to give written informed consent Exclusion Criteria: Patients with additional lower limb injuries Patients with abnormal lower limb vasculature Pregnant or lactating women Unexplained abnormal baseline laboratory results Males and females who are capable of reproduction and will not take acceptable measures to prevent reproduction during the study Subjects who test positive for HTLV, HIV, hepatitis B or hepatitis C, have a chronic inflammatory disease, autoimmune disease or are on chronic immunosuppressive medications History of alcohol or drug abuse within 3 months of screening Subjects with evidence (clinical, laboratory, or imaging) of cancer or cancer recurrence within the past 5 years (other than non-melanoma skin cancer or in situ cervical carcinoma) Currently enrolled in another investigational device or drug trial that has not completed the required follow-up period Patients unable to give written informed consent

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Other: CD34+ haemopoietic stem cells<br>* Expanded subset of CD34+ haemopoietic stem cell. Harvested from pelvic marrow aspiration at Day 0 of study. Undergoes refinement and minimum of 1000 fold expansion over 7 days in a dose escalation regime of a maximum dose of 1,000,000,000 cells in 5 millilitres. Injected at Day 7 via contralateral femoral artery under angiographic guidance. First regime up to 10,000,000 cells, second 100,000,000 cells, final regime maximum of 1,000,000,000 cells.<br>* Other names: Omnicyte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of expanded autologous progeny of an adult CD34+ stem cell subset when introduced into the tibial artery and to determine absence of adverse events at the maximum dose of cells of 1,000,000,000 cells in a dose escalation regime. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess improvement in bony union as measured by imaging modalities and determine whether there are any significant improvements in early restoration of function as reported by the patients. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fracture, tibia, stem cell