A multi-centre phase I/II safety and tolerability study following the infusion of expanded autologous progeny of an adult CD34 positive stem cell subset to patients with recent tibial fractures.
- Conditions
- Fractured Tibia
- Registration Number
- EUCTR2006-004521-28-GB
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 32
Male or female patients aged 17 years and above
Confirmed closed tibial fracture
Normal blood count
Normal coagulation screen
Life expectancy of at least 12 months
Able to give written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients below the age of 17 years
Pregnant or lactating women
Patients with unexplained abnormal baseline laboratory results
Patients who test positive for HIV, HTLV, Hepatitis B or C, have a chronic inflammatory disease, autoimmune disease or who are on chronic immunosupressive medications.
Patients with a history of alcohol or drug abuse within 3 months of screening
Patients with evidence of cancer or cancer recurrence within the past 5 years (other than non-melanoma skin cancer or in-situ cervical carcinoma)
Patients unable to give written informed consent
Patients who have been involved in any other trial that has not completed the required follow-up period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the safety and tolerability of expanded autologous progeny of an adult CD34+ stem cell subset when infused directly into the tibial artery of patients with recent fractures of the tibia. ;Secondary Objective: The trial will seek to determine clinical improvement or deterioration by measurement of clinical parameters such as length of time to union of fracture, changes in bone density, improvement in pain scores (VAS), functional ability (TUGT) and IPAQ scores.;Primary end point(s): 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 expanded cells of 1 x 10 to the 9 cells/5.0mL.
- Secondary Outcome Measures
Name Time Method