Stem Cells and Tibial Fractures (STIF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00632034
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : February 22, 2016
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
Tibial Fractures Other: CD34+ haemopoietic stem cells Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   17 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: May 2010

Keywords provided by Imperial College London:
stem cell

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries