Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-004521-28 | EudraCT Number |
Not provided
Not provided
No funding
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sean P.F. Hughes, MS | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10862779 | Background | 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. | |
| 9698003 | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 8168299 | 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. |
| 10086817 | 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. |
| 11314793 | 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. |
| 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 |
| 6332920 | 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. |
| 14216447 | 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. |
| 9142444 | 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. |
| 13143788 | 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. |
| 16798982 | 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. |
| 12063342 | 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. |
| 9546453 | 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. |
| 15046426 | 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. |