Stem Cells and Tibial Fractures

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

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.

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