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Stem Cells and Tibial Fractures (STIF)

This study has been completed.
Information provided by (Responsible Party):
Imperial College London Identifier:
First received: February 29, 2008
Last updated: February 19, 2016
Last verified: May 2010
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.

Condition Intervention Phase
Tibial Fractures
Other: CD34+ haemopoietic stem cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: May 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Other Name: Omnicyte


Ages Eligible for Study:   17 Years to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00632034

United Kingdom
Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Principal Investigator: Sean P.F. Hughes, MS Imperial College London
  More Information

Grazier KL, Holbrook TL, Kelsey JL, Stauffer RN. The frequency of occurrence, impact, and cost of musculoskeletal conditions in the United States. American Academy of orthopaedic Surgeons Chicago IL, USA. 1984

Responsible Party: Imperial College London Identifier: NCT00632034     History of Changes
Other Study ID Numbers: HHSC/010  2006-004521-28 
Study First Received: February 29, 2008
Last Updated: February 19, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
stem cell

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries processed this record on October 21, 2016