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

Imperial College London1 site in 1 countryMay 2010

ConditionsTibial Fractures

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tibial Fractures
Sponsor: Imperial College London
Locations: 1
Primary Endpoint: 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.
Status: Withdrawn
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

July 2012

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Imperial College London

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: 1 year

Secondary Outcomes

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)