Status:
WITHDRAWN
Stem Cells and Tibial Fractures
Lead Sponsor:
Imperial College London
Conditions:
Tibial Fractures
Eligibility:
All Genders
17-75 years
Phase:
NA
Brief Summary
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00632034
Start Date
May 1 2010
End Date
July 1 2012
Last Update
July 15 2019
Active Locations (1)
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1
Charing Cross Hospital
London, United Kingdom, W6 8RF