Stem Cells and Tibial Fractures Ver 4.00

• Research type

  Research Study

• Full title

  A phase I safety and tolerability study following the infusion of expanded autologous bone marrow derived adult haematopoietic stem cell progenitors to patients with recent tibial fractures

• Contact name

  Yuin Chung Lok

• Sponsor organisation

  Imperial College London

• Eudract number

  2006−004521−28

• ISRCTN Number

  ISRCTN

• Clinicaltrials.gov Identifier

  NCT

• Research summary

  Despite advances in operative techniques, the healing time still remain about 4 months for lower limb fractures. Stem cells are the basic units of growth and repair. We have discovered a special group of haemopoietic stem cells which has the ability to grow and mature into many different cell types, including bone and blood vessels, an essential cofactor in any form of healing. In addition, we can harvest them from the patients we want to treat, and we have developed reliable methods to expand their numbers. We believe when administered in expanded numbers to patients with fractures, these stem cells can speed up the healing process, and get them moving much sooner. We propose a pilot study to assess the safety of using stem cells to enhance the treatment of leg fractures. Our inclusion criteria are patients with confirmed closed fracture (break) of one leg above the age of 17. Consent will be sought and recruited patients will be screened for various blood-borne viruses such as hepatitis and HIV. They will undergo intramedullary nailing (insertion of a metal rod down the hollow shaft of the bone) as is the usual treatment for a broken leg. During the same general anaesthesia, their stem cells will be harvested by inserting a needle into their pelvis to suck up bone marrow. The harvested marrow will then be purified for the stem cells, and the cells themselves grown in a lab. The whole process takes 7 days, and on the 8th day, patients will be readmitted to have their own stem cells, now expanded in number, reinjected near the site of the break through the femoral artery (in the groin). Their progress will then be monitored for up to 1 year using X-rays,activity tests and activity questionnaires.

• REC name

  London - Central Research Ethics Committee

• REC reference

  09/H0718/4

• Date of REC Opinion

  30 Jun 2009

• REC opinion

  Favourable Opinion