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Stem Cells and Tibial Fractures (STIF)

Primary Purpose

Tibial Fractures

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CD34+ haemopoietic stem cells
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fractures focused on measuring fracture, tibia, stem cell

Eligibility Criteria

17 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charing Cross Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

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.

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.

Full Information

First Posted
February 29, 2008
Last Updated
July 11, 2019
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT00632034
Brief Title
Stem Cells and Tibial Fractures
Acronym
STIF
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 Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
May 2010 (Anticipated)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures
Keywords
fracture, tibia, stem cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
CD34+ haemopoietic stem cells
Other Intervention Name(s)
Omnicyte
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean P.F. Hughes, MS
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
10862779
Citation
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.
Results Reference
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PubMed Identifier
9698003
Citation
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.
Results Reference
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PubMed Identifier
8168299
Citation
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.
Results Reference
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PubMed Identifier
10086817
Citation
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.
Results Reference
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PubMed Identifier
11314793
Citation
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.
Results Reference
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Citation
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
Results Reference
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PubMed Identifier
6332920
Citation
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.
Results Reference
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PubMed Identifier
14216447
Citation
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.
Results Reference
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PubMed Identifier
9142444
Citation
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.
Results Reference
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PubMed Identifier
13143788
Citation
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.
Results Reference
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PubMed Identifier
16798982
Citation
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.
Results Reference
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PubMed Identifier
12063342
Citation
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.
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PubMed Identifier
9546453
Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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Stem Cells and Tibial Fractures

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