Stem Cells and Tibial Fractures - Full Text View

Sponsored by:	Imperial College London
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00632034

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Fractures

U.S. FDA Resources

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
1: Experimental	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.
2: No Intervention

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

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
London, United Kingdom, W6 8RF
Ealing General Hospital
London, United Kingdom, UB1 3HW
West Middlesex University Hospital
London, United Kingdom, TW7 6AF
North Middlesex University Hospital
London, United Kingdom, N18 1QX

Sponsors and Collaborators

Imperial College London

Investigators

Principal Investigator:

Sean P.F. Hughes, MS

Imperial College London

More Information

Publications:

Bianco P, Gehron Robey P. Marrow stromal stem cells. J Clin Invest. 2000 Jun;105(12):1663-8. Review. No abstract available.

Bruder SP, Kraus KH, Goldberg VM, Kadiyala S. The effect of implants loaded with autologous mesenchymal stem cells on the healing of canine segmental bone defects. J Bone Joint Surg Am. 1998 Jul;80(7):985-96.

Dickson K, Katzman S, Delgado E, Contreras D. Delayed unions and nonunions of open tibial fractures. Correlation with arteriography results. Clin Orthop Relat Res. 1994 May;(302):189-93.

Dunlop DD, Hughes SL, Edelman P, Singer RM, Chang RW. Impact of joint impairment on disability-specific domains at four years. J Clin Epidemiol. 1998 Dec;51(12):1253-61.

Friedlaender GE, Perry CR, Cole JD, Cook SD, Cierny G, Muschler GF, Zych GA, Calhoun JH, LaForte AJ, Yin S. Osteogenic protein-1 (bone morphogenetic protein-7) in the treatment of tibial nonunions. J Bone Joint Surg Am. 2001;83-A Suppl 1(Pt 2):S151-8.

Heppenstall RB, Brighton CT, Esterhai JL Jr, Muller G. Prognostic factors in nonunion of the tibia: an evaluation of 185 cases treated with constant direct current. J Trauma. 1984 Sep;24(9):790-5.

NICOLL EA. FRACTURES OF THE TIBIAL SHAFT. A SURVEY OF 705 CASES. J Bone Joint Surg Br. 1964 Aug;46:373-87. No abstract available.

Kadiyala S, Young RG, Thiede MA, Bruder SP. Culture expanded canine mesenchymal stem cells possess osteochondrogenic potential in vivo and in vitro. Cell Transplant. 1997 Mar-Apr;6(2):125-34.

KUNTSCHER G. [Medullary nailing of fractures of tibial shaft.] Langenbecks Arch Klin Chir Ver Dtsch Z Chir. 1953;276:217-27. Undetermined Language. No abstract available.

Lee EH, Hui JH. The potential of stem cells in orthopaedic surgery. J Bone Joint Surg Br. 2006 Jul;88(7):841-51. Review. No abstract available.

Lieberman JR, Daluiski A, Einhorn TA. The role of growth factors in the repair of bone. Biology and clinical applications. J Bone Joint Surg Am. 2002 Jun;84-A(6):1032-44. Review. No abstract available.

Singer BR, McLauchlan GJ, Robinson CM, Christie J. Epidemiology of fractures in 15,000 adults: the influence of age and gender. J Bone Joint Surg Br. 1998 Mar;80(2):243-8.

Vats A, Tolley NS, Buttery LD, Polak JM. The stem cell in orthopaedic surgery. J Bone Joint Surg Br. 2004 Mar;86(2):159-64. Review. No abstract available.

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

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Tibial Fractures

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Tibial Fractures

ClinicalTrials.gov processed this record on September 10, 2009