This was posted by Frankhair1 a few days ago:
http://www.intermarkltd.com/ClinicalTrialPressRelease.htm
LONDON - CHOSEN LOCATION FOR PIONEERING CLINICAL STUDY
Source: InterMark Associates, Ltd.
Aderans Research initiates Phase 1 clinical trial for autologous cellular treatment of hair loss.
UK plans are unveiled for the commencement of Phase 1 clinical studies for the treatment of hair loss using unique tissue engineering techniques
London, United Kingdom, July, 2006 – Aderans Research, the specialist tissue engineering research group for hair loss, has announced plans for the commencement of London based clinical studies for the treatment of hair loss using its unique tissue engineering technique, a bio engineered hair loss solution that cultivates a persons own cells to overcome the problem of insufficient hair supply and pattern baldness.
The Aderans Research proposed solution has received Guy’s and St Thomas’ and King’s hospital approvals by the East London and the City research ethics committee for the Phase 1 trial. Subjects taking part in the study will be treated at private clinics located at London Bridge hospital and Harley Street.
The treatment under study proposes to overcome a key limitation of conventional surgical hair transplantation by creating new hair growth. Current procedures are limited by one central problem – each patient has only a finite number of hair follicles for redistribution with approximately 100,000 follicles in place at birth. Thus, once hair loss starts, the head of hair that each person has at that moment in time is the most hair that they can expect for the rest of their lives.
With the Aderans Research proposed technique, clinicians may be able to grow as many of the person’s own cells as necessary to increase normal hair growth and the treatment can be repeated to ensure high quality hair restoration results.
Under the Aderans Research process, doctors use a minimally invasive biopsy procedure to remove a small amount of tissue from the scalp. Hair forming cells are extracted and allowed to multiply under tightly controlled cGMP laboratory conditions. Once sufficient new cells are formed, they are then injected into the patient’s scalp with a tiny needle.
Aderans Research, in conjunction with InterMark Associates Ltd, the medical technology consulting specialists and clinical research organisation (CRO) for the study, have identified lead investigators to initiate the clinical trials for the application of the new treatment for hair loss. Mr Chris Inglefield, a leading plastic and reconstructive surgeon, based at London Bridge Hospital, is the principal investigator and Dr Alan Kingdon, medical director of the cosmetic surgery clinic in Harley Street, London, the co-investigator. Dr Mark Lewis, director of research operations at the Eastman Dental Institute of University College London, will act as the study’s medical monitor.
Mr Chris Inglefield, commenting on the trial, said: “This unique process aims to provide hair growth for both men and women who are not catered for by current hair transplant and surgical techniques. By harvesting and expanding the hair cells to many millions, this process may be able to restore normal hair density.”
Dr. Mark Lewis added: “Although a great deal of biological research has been, and continues to be, conducted into autologous cell therapies, the number of actual patient interventions available remains low. This trial represents the cutting edge of cell engineering investigations with the subjects own hair follicle cells (comprising 2 cell types) being placed into their balding scalp.”
Robert Sexauer, managing director of InterMark Associates, said: “The Aderans cellular engineering and treatment process may emerge as a significant contribution to the expanding medical use of a person’s own cells for restorative purposes.”
