Tibial FracturesSTIFNCT00632034
Stem Cells and Tibial Fractures
A study testing CD34+ haemopoietic stem cells in people with Tibial Fractures, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- CD34+ haemopoietic stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- CD34+ haemopoietic stem cells
- Keywords
- fracture, tibia, stem cell
- Medical subject headings
- Tibial Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD34+ haemopoietic stem cellsOther
Also called Omnicyte
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: CD34+ haemopoietic stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startMay 2010 (estimated)
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean P.F. Hughes, MS, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632034
- Sponsor's protocol ID
- HHSC/010
- Other IDs
- 2006-004521-28
- Acronym
- STIF
- Status last verified
- Jul 2019
- First submitted
- 29 Feb 2008
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10862779Bruder 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.
PubMed 9698003Dickson 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.
PubMed 8168299Dunlop 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.
PubMed 10086817Friedlaender 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.
PubMed 11314793Grazier 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
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.
PubMed 6332920NICOLL EA. FRACTURES OF THE TIBIAL SHAFT. A SURVEY OF 705 CASES. J Bone Joint Surg Br. 1964 Aug;46:373-87. No abstract available.
PubMed 14216447Kadiyala 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.
PubMed 9142444KUNTSCHER 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.
PubMed 13143788Lee 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.
PubMed 16798982Lieberman 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.
PubMed 12063342Singer 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.
PubMed 9546453Vats 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.
PubMed 15046426
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00632034
- Acronym / sponsor ID
- STIF / HHSC/010
- Conditions
- Tibial Fractures
- Keywords
- fracture, tibia, stem cell
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- May 2010 (estimated)
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: CD34+ haemopoietic stem cells |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD34+ haemopoietic stem cellsAlso: OmnicyteExpanded 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 | 1 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Background: PubMed 10862779Bianco P, Gehron Robey P. Marrow stromal stem cells. J Clin Invest. 2000 Jun;105(12):1663-8. doi: 10.1172/JCI10413. No abstract available.
- Background: PubMed 9698003Bruder 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.
- Background: PubMed 8168299Dickson 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.
- Background: PubMed 10086817Dunlop 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.
- Background: PubMed 11314793Friedlaender 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.
- BackgroundGrazier 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: PubMed 6332920Heppenstall 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.
- Background: PubMed 14216447NICOLL EA. FRACTURES OF THE TIBIAL SHAFT. A SURVEY OF 705 CASES. J Bone Joint Surg Br. 1964 Aug;46:373-87. No abstract available.
- Background: PubMed 9142444Kadiyala 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.
- Background: PubMed 13143788KUNTSCHER 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.
- Background: PubMed 16798982Lee 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.
- Background: PubMed 12063342Lieberman 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean P.F. Hughes, MS principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD34+ haemopoietic stem cells in people with Tibial Fractures, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00632034, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.