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Stem Cells and Tibial Fractures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Imperial College London.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00632034
First received: February 29, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Centre Phase I/II Safety and Tolerability 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 x 109 cells in 5.0mL. [ 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 ]

Estimated Enrollment: 32
Study Start Date: April 2008
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2010 (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 up to maximum dose of 1000,000,000 cells in 5 millilitres. Injected at Day 7 via contralateral femoral artery under angiographic guidance.
Other Name: Omnicyte
No Intervention: 2

  Eligibility

Ages Eligible for Study:   17 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00632034

Contacts
Contact: Sean P.F. Hughes, MS +442083832021 s.hughes@imperial.ac.uk
Contact: Yuin Chung Lok, MBBS +447786131325 y.lok07@imperial.ac.uk

Locations
United Kingdom
Charing Cross Hospital Active, not recruiting
London, United Kingdom, W6 8RF
Ealing General Hospital Not yet recruiting
London, United Kingdom, UB1 3HW
Contact: Enrique Saavedra    +442089675618    Enrique.saavedra@eht.nhs.uk   
Principal Investigator: Enrique Saavedra         
North Middlesex University Hospital Not yet recruiting
London, United Kingdom, N18 1QX
Contact: R Ravikumar    02088872000      
Principal Investigator: R Ravikumar         
West Middlesex University Hospital Not yet recruiting
London, United Kingdom, TW7 6AF
Contact: K Desai    +4402085605910    Jo.knapp@wmuh.co.net   
Principal Investigator: K Desai         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Sean P.F. Hughes, MS Imperial College London
  More Information

Publications:

Responsible Party: Professor Sean P.F. Hughes, Imperial College London
ClinicalTrials.gov Identifier: NCT00632034     History of Changes
Other Study ID Numbers: HHSC/010, 2006-004521-28
Study First Received: February 29, 2008
Last Updated: February 29, 2008
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:
fracture
tibia
stem cell

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

ClinicalTrials.gov processed this record on November 20, 2014