Stem Cells and Tibial Fractures (STIF)

Imperial College London

Status

Withdrawn

Conditions

Tibial Fractures

Treatments

Other: CD34+ haemopoietic stem cells

Study type

Interventional

Funder types

Other

Identifiers

NCT00632034

2006-004521-28 (EudraCT Number)

HHSC/010

Details and patient eligibility

About

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.

Sex

All

Ages

17 to 75 years old

Volunteers

No Healthy Volunteers

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