Allora vi aggiorno da parte di chicca [
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Citazione:Intercytex
They are a research company and are not conducting any trials at present. They have just finished phase II of trials & have no specific plans for phase III yet. They expect to publish the Phase II results at the end of Q1 on the website. They will also use their website to recruit patients for Phase III when they are ready for this. They do not keep lists or contact people but rely on their website so they recommend watching the website.
Farjo Institute
I could only speak to the receptionist but they are planning some trials in March / April & will send me an application form on Monday. Once we have this I will follow-up.
Both said that location was important as frequent tests need to be done so easy access to the clinics is important.
Una seconda mail:
Citazione:Thank you for your enquiry regarding the hair trials. The trial company (Intercytex) are hoping to hold further clinical trials (phase III) in the near future, though at present the trial design is under development and there are no timelines regarding this phase.
When further information is available it will be posted on the web site, Please feel free to consult www.intercytex.com
<http://www.intercytex.com for potential updates. In the meantime we will keep your details on our database and forward you any up to
date information.
Regards
On behalf of Farjo Medical Centre
C'era un allegato, ve lo copio...
Citazione:
PATIENT INFORMATION SHEET
(Lifestyle Questionnaire and Viral Blood Testing)
Title of Study: A Phase lIa Uncontrolled Study To Evaluate Hair Growth In Subjects With Male-Pattern Baldness Using A Cell Suspension Of Expanded Autologous Dermal Papilla Cells (ICX-TRC)
Researcher: Dr Bessam Farjo
Patient Name: _
In order to provide protection to patients and research staff from the possibility of transmittable diseases, samples cannot be taken from donors infected with human pathogens including Human Immunodeficiency Virus (HIV) or belonging to high-risk groups associated with infectious diseases.
To be able to donate tissue in this study it is important that you have not been exposed to certain blood borne infectious diseases.
This will be assessed through the use of a lifestyle questionnaire and a blood test, in accordance with Department of Health Guidelines that aim to prevent infection following donation of human tissues.
Pre-test Counsellinq
Pre-test counselling will be provided to all patients wishing to participate in the study. This is to discuss having blood tests performed, how you will be informed of results and who to go to should you wish to receive further information. Counselling will be performed by a trained counsellor, at the Xxxxxx and prior to a blood sample being taken.
Lifestvle Questionnaire
The lifestyle questionnaire will ask some relatively personal questions about your sexual history and past lifestyle.
Viral Blood Tests
A sample of your blood will be sent to a local accredited laboratory and screened for specific transmissible diseases. The screening tests will include tests for previous exposure to infectious agents such as HIV, Hepatitis B, Hepatitis C and Syphilis. Tests will be repeated once after three months to confirm the initial results.
In order to carry out the blood tests, the nurse will need to take a teaspoon full (5 ml) of blood from you.
What are the risks to vou of QivinQ a sample of blood?
It is possible that you may have a small bruise at the site from where the blood sample was taken. The only hazards that may be imposed are those consistent with taking blood i.e. pain at the site of needle puncture, possible bruising and rarely fainting.
Results
Results of the tests will be sent to the Investigator looking after you. These will be stored confidentially with your Xxxxxx notes.
Negative results: When negative tests results are returned you will be able to continue your participation in the study.
Positive results: All positive results will be disclosed to you. If any of the test results are positive a repeat test will be undertaken to ensure the result is correct. If the repeat test is found to be positive, a confirmatory test is performed. You will not need to provide a second blood sample.
Should any of the results test positive on the repeat test, the Investigator will notify you in a confidential manner. You will be unable to continue with the study.
With your written consent you will be referred back to a trained counsellor for medical support. The counsellor will discuss the result with you and your close family if you so wish. The counsellor's support is free of charge and available at your discretion.
With written permission, the results will be forwarded to your G.P.
Confidentiality
Should you decide to participate in the study you will be identified by a unique identification number. This number is used in all references to your blood and tissues and prevents you from being identified as a donor. The research staff will only have access to your name, and your personal details will be kept confidential at all times. Your rights are protected under the Data Protection Act, 1998.
Consent
If you do decide to continue with the study you will be given this information sheet to keep and you will be asked to sign a consent form indicating that you agree to take part in the study and that you are willing to have your blood tested for the diseases described including HIV.
Who to contact
If you have any further questions about the procedures, tests or any related issues, either now or later, please do not hesitate to contact the Xxxxxx.
PATIENT INFORMATION SHEET (General)
All correspondence:
Farjo Medical Centre Arthur House Chorlton Street Manchester Ml 3FH
130 Harley Street London WIG 7JU
Tel: 0870 7555 495 International: (+44) 1612373517 Fax: 0161 2373279
wvvwJarjo.com info@farjo.com
Title of Study:
Researcher:
Patient Name:
Part 1
A Phase lIa Uncontrolled Study To Evaluate Hair Growth In Subjects With Male-Pattern Baldness Using A Cell Suspension Of Expanded Autologous Dermal Papilla Cells (ICXTRC)
Dr. Bessam Farjo
Introduction
You are being invited to take part in a research study. Before you decide whether you want to take part, it is important for you to understand why the research is being done and what it will involve. Please take the time to read the following information carefully and discuss it with others if you wish .
• Part 1 tells you the purpose of this studyand what will happen to you if you decide to take part.
• Part 2 gives you more detailed information about the conduct of the study.
Ask a member of the research team if there is anything that is not clear or if you would like more information.
Take the time to decide whether or not you wish to take part.
Thank you for reading this.
What is the purpose of the study?
This study is being conducted to evaluate a new product called 'ICX-TRC' that has been developed to treat patients with Male Pattern Baldness (MPB). MPS or Androgenetic Alopecia is thought to result from a change in the size of hair follicles on the head. This type of hair loss is known to progress with age and is particularly prominent in men over 25 years. A common way of treating hair loss is to take a small sample of your skin under local anaesthetic from the back of the head and
