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Stem Cells and Tibial Fractures

NCT00632034 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-07-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Sean P.F. Hughes, MS · Imperial College London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00632034 on ClinicalTrials.gov