Clinical trial NCT00632034: Stem Cells and Tibial Fractures
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tibial Fractures
Keywords: fracture
tibia
stem cell
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2008-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: Imperial College London
name: Sean P.F. Hughes, MS
role: PRINCIPAL_INVESTIGATOR
References:
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