Stem Cells and Tibial Fractures

NCT00632034 | Withdrawn DMC

• 2 other identifiers: HHSC/0102006-004521-28
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Tibial Fractures

Keywords

fracture; tibia; stem cell

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (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.

  1 year

Study Arms (1)

1

EXPERIMENTAL

Other: CD34+ haemopoietic stem cells

Interventions

CD34+ haemopoietic stem cells OTHER

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.

Also known as: Omnicyte

1

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Related Publications (14)

• Bianco P, Gehron Robey P. Marrow stromal stem cells. J Clin Invest. 2000 Jun;105(12):1663-8. doi: 10.1172/JCI10413. No abstract available.

  PMID: 10862779 BACKGROUND

• 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. doi: 10.2106/00004623-199807000-00007.

  PMID: 9698003 BACKGROUND

• 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.

  PMID: 8168299 BACKGROUND

• 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. doi: 10.1016/s0895-4356(98)00128-0.

  PMID: 10086817 BACKGROUND

• 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.

  PMID: 11314793 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 6332920 BACKGROUND

• 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.

  PMID: 14216447 BACKGROUND

• 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. doi: 10.1177/096368979700600206.

  PMID: 9142444 BACKGROUND

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

  PMID: 13143788 BACKGROUND

• Lee EH, Hui JH. The potential of stem cells in orthopaedic surgery. J Bone Joint Surg Br. 2006 Jul;88(7):841-51. doi: 10.1302/0301-620X.88B7.17305. No abstract available.

  PMID: 16798982 BACKGROUND

• 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(6):1032-44. doi: 10.2106/00004623-200206000-00022. No abstract available.

  PMID: 12063342 BACKGROUND

• 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. doi: 10.1302/0301-620x.80b2.7762.

  PMID: 9546453 BACKGROUND

• 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. doi: 10.1302/0301-620x.86b2.14756. No abstract available.

  PMID: 15046426 BACKGROUND

MeSH Terms

Conditions

Tibial Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Study Officials

• Sean P.F. Hughes, MS

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 10, 2008
• Study Start: May 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

GB (1)