NCT00632034

Stem Cells and Tibial Fractures

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 17 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tibial Fractures

Interventions

Type	Name	Description
OTHER	CD34+ haemopoietic stem cells	Expanded subset of CD34+ haemopoietic stem cell. Harvested from pelvic marrow aspiration at Day 0 of study. Undergoes refinement and minimum of 1000 fold expansion over 7 days in a dose escalation regime of a maximum dose of 1,000,000,000 cells in 5 millilitres. Injected at Day 7 via contralateral femoral artery under angiographic guidance. First regime up to 10,000,000 cells, second 100,000,000 cells, final regime maximum of 1,000,000,000 cells.

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2008-03-10
• Last updated: 2019-07-15

Locations

1 site across 1 country: United Kingdom