voila ce que j'ai resus du dr huang
tdelrieu ci tu peux nous traduire merci
Dear Mr. Adolphe Guerdener,
Thank you for you’re interested for this experimental treatment to be
performed by Prof. Huang in China.
I am Dr. Chen Lin, an assistant for Prof. Huang.
I will send the protocol of this experimental treatment to you as
attachment right now.
I hope there are answers to your questions available in the protocol.
Any questions I would like to discuss with you soon.
Regards,
Dr. Chen Lin
*****************************************************
Dr. CHEN Lin
Attending Neurosurgeon, Department of Neurosurgery,
Beijing Xishan Hospital,
Beijing Xishan Institute for Neuroregeneration and Functional Recovery in
Shijingshan district
Xi xia zhuang, Ba da chu, Shijingshan District,
Beijing 100041, CHINA
Email:
chenlin_china@163.com chenlin_china@hotmail.comFax: (86-10) 5162-5950
Tel: (86-10) 5162-5646
http://www.nrrfr.com******************************************************
Clinical Research Studies
Beijing Xishan Institute for Neuroregeneration and Functional Recovery in Shijingshan District
Department of Neurosurgery, Beijing Xishan Hospital & Beijing Rehabilitation Center
International Neurological Disorders Research & Treatment Center, Qingdao Wanjie Hospital
Protocol Number: 06-A-01
Title: Experimental treatment investigating the efficacy of Schwann cell and olfactory ensheathing cell transplantation for the treatment of chronic complete cervical spinal cord injury
Protocol Number: 06-A-01
Purpose: We are planning to conduct a clinical study to examine the benefits of using Schwann cells combined with or without olfactory ensheathing cell in treating chronic complete cervical spinal cord injuries. We will compare the efficacy of three different neurosurgical interventions with a control group: transplantation of olfactory ensheathing cells (OEC), transplantation of Schwann cells, and transplantation of OEC combined with Schwann cells.
Study Type: treatment trials
Study Design: prospective randomized double blinded clinical experimental treatment
Expected Total Enrollment: 28
Study Start Date: May 15, 2006
Study Duration: 12 months
Study Population
Inclusion Criteria
Patients will be enrolled in this study only if they meet all of the following criteria:
At least 12 months post-injury.
Informed Consent Form signed by the patient or patient’s legal representative.
Male or female, aged ≤60 years, inclusive.
Cervical (C4-C7) spinal cord injury.
ASIA Impairment Scale grade of A (complete, no motor or sensory function present in the sacral segment) as assessed within 6 months before surgery.
Able to communicate effectively to obtain informed consent and to ensure neurological examination.
Exclusion Criteria
Patients will not be enrolled in this study if any of the following conditions obtain:
Any functional recovery demonstrated during the 6 month period leading up to surgery.
Use of any experimental drug, or participation in any clinical trial, within one and a half year during the study.
Any medical condition that may interfere with the ASIA and Xishan SCI Functional Rating Scale assessments.
Clinically significant neurological, cardiac, respiratory, hepatic, or renal disease and/or malignancy.
Hemophilia or other bleeding abnormality as defined by:
a) Platelet level lower than 100×109/L
b) Activated partial thromboplastin time or international normalized ratio higher than the upper limit of normal range
c) Baseline hematocrit lower than 0.25
Any cognitive impairments which may preclude accurate neurological assessments (e.g. traumatic head injury with GCS of less than or equal to 14).
Ankylosing Spondylitis.
Diabetes mellitus requiring insulin therapy.
Known immunodeficiencies, including Acquired Immune Deficiency Syndrome or use of immunosuppressive or cancer chemotherapeutic drugs.
Pregnancy or breastfeeding during the study. A serum pregnancy test will be performed at Screening for female patients of childbearing potential. In addition, patients who are considered likely to be pregnant may be excluded at the Investigator’s discretion.
Any condition or situation likely to cause the patient to be unable or unwilling to participate in study procedures or participate in all scheduled study assessments, including follow up through the twelfth month of the study.
Any pre-existing condition likely to result in the patient’s death within the next 12 months.
Non-traumatic causes of spinal cord injury (e.g. transverse myelitis, acute disc herniation, etc…).
Any neuroimaging evidence of compression to the spinal cord (e.g., by fractured vertebrae or disc).
Any neuroimaging evidence of transecting injury to the spinal cord (e.g., by stab wound).
Any infections or pressure sores at the site of surgery.
Any condition or situation likely to cause the patient to be unable to undergo rehabilitation procedures.
Any other condition that, in the opinion of the Investigator, would preclude the patient’s participation in the study.
Sponsoring Research Institution:
Beijing Xishan Institute for Neuroregeneration and Functional Recovery in Shijingshan District, Beijing Xishan Hospital & Beijing Rehabilitation Center, and Qindao Wanjie Hospital
Primary Investigator:
Professor HUANG Hongyun
Experimental Protocol Researchers:
Attending Neurosurgeons (in charge of surgical procedure administration)
Attending Neurologists (in charge of gathering relevant medical information and neurological function assessments to be conducted one week prior to surgery, then one week, 3 weeks, and 6 months after the surgery)
Local Neurologist, Neurosurgeon or Orthopedic Surgeon (in charge of gathering relevant medical information and neurological function assessments at six months and one week prior to coming to China for surgery)
Statisticians (in charge of study design and statistical analyses)
Laboratory technicians (in charge of cell culture and cell type matching)
Benefits of Participation:
By participating in this experimental study, patients will have access to the most advanced clinical treatments available for treating human spinal cord injuries. Our previous clinical experience has demonstrated that OEC transplantation is effective in treating chronic SCI1-2. In this clinical trial, we will be examining whether Schwann cells alone or in combination with OECs are also effective in treating chronic SCI3. Once we determine which cell transplantation strategy is the most effective at the conclusion of the study, participants who have undergone the other cell transplantation initially will have the option of receiving a free extra surgery using the method that has been shown to be most effective in promoting functional recovery.
The Beijing Xishan Institute for Neuroregeneration and Functional Recovery in Shijingshan District will pay for all costs associated with the cell preparation and follow-up examination. Six months after the initial surgery, we will provide each participant and one accompanying caregiver with free roundtrip economy class airplane tickets to China, free housing and meals during the follow-up stay, and free medical examinations including all neurological assessments. As noted above, we will also offer participants a free extra surgery using the best cell transplantation strategy (based on the results of this study) for promoting functional recovery.
Please note that the participant will still be responsible for paying the costs associated with the initial surgical procedure itself (including initial hospitalization, medications, anesthesia, surgical fees, etc.) during the participant's first trip to China. We anticipate that the costs to the participant will be approximately $10,000 USD, which is significantly less than the cost of receiving the standard OEC treatment.
Experimental Procedure and Assessment:
Prospective study participants will be evaluated six months before the scheduled surgery date by undergoing a neurological assessment examination and magnetic resonance imaging (MRI) scan. The local neurologist, neurosurgeon, orthopedic surgeon, or neurological rehabilitation therapist will fill out two neurological assessment forms: (1) the American Spinal Cord Injury Association (ASIA) Scale (Assessment Form A) and (2) the Xishan SCI Functional Rating Scale (Assessment Form B). Prospective participants must then engage in a rigorous physical therapy regimen for the next six months, training at least six hours per day, five days per week. This is to rule out the possibility that physical therapy may result in functional recovery without the cell transplantation. A subsequent neurological assessment including (1) the American Spinal Cord Injury Association (ASIA) Scale (Assessment Form C) and (2) the Xishan SCI Functional Rating Scale (Assessment Form D) will be performed approximately one week before coming to China for the surgery and all Assessment Form A, B, C, and D described above request to be sent to our Institute via Email or Fax. If the physical therapy results in any functional improvement during the observed period, the patient will be ineligible for participation in this clinical study (although they will have the option to receive the standard OEC treatment if desired).
28 eligible participants will be selected and randomly divided into four groups of 7 participants each. Eligible participants in three treated group will then come to China to receive fetal cell transplantation at two sites surrounding the damaged area of spinal cord; one control group just come to China for functional assessment. Please note that this is a comparison study without placebo administration, and all participants of these three treated groups will receive active experimental treatment. Group A will receive transplantation of olfactory ensheathing cells (OEC) only. Group B will receive transplantation of Schwann cells only, Group C will receive transplantation of OEC combined with Schwann cells, and Group D (control group) will only get functional assessment.
Participants will be given follow up neurological assessments one week, three weeks, and six months after the initial evaluation or surgery. The first two neurological assessments will be performed during the participant's first trip to China, and the final post-surgery examination will be performed during the participant's second trip to China. The neurological assessments will be performed according to the ASIA and Xishan SCI Functional Rating Scales, electromyography, evoked potential, and pulmonary function exams.
Participants in all three treated groups and the control group will be instructed to undergo a rigorous physical therapy regimen for at least six months following the surgical transplantation, in between the two China visits. Our previous clinical experience has shown that patients must undergo intensive physical training in order to achieve maximum benefit from the implanted cells. We anticipate that participants will stay in China during this first trip for approximately 30 days; the control group will stay in China for one week. The control group (Group D) will also continue engaging in a rigorous physical therapy regimen for the next six months, training at least six hours per day, five days per week.
Another MRI will be performed six months after surgery.
Statistical Analysis:
The statistical analysis will be conducted by statisticians.
The data is expressed as means of ±SD. Using SPSS for Windows (version 10.0; SPSS, Inc., Chicago, IL), Paired-samples T test are performed for the comparisons of the ASIA Scores and Xishan SCI Functional Rating Scale (SCI-FRS) Scores before and after transplantation. Then one-way ANOVA are performed for the comparisons of the change of ASIA Scores and Xishan SCI-FRS Scores among 4 groups. A significance level of 0.05 was used.
Comments:
This clinical trial is being reviewed by the ethical review board of the Beijing Xishan Institute for Neuroregeneration and Functional Recovery in Shijingshan District, Beijing Xishan Hospital & Beijing Rehabilitation Center, and Qindao Wanjie Hospital.
Before entering the research study, all participants will be required to provide written consent by signing the “Experimental Treatment for Spinal Cord Injured Patients Participation Agreement” (see attached form).
Reference
Huang HY, Chen L, Wang HM, et al. Influence of patients’ age on functional recovery after transplantation of olfactory ensheathing cells into injured spinal cord injury. Chin Med J. 2003; 116(10):1488-91
Huang HY, Wang HM, Chen L, et al. Influence factors for functional improvement after olfactory ensheathing cell transplantation for chronic spinal cord injury. Chinese Journal of Reparative and Reconstructive Surgery (Zhongguo Xiu Fu Chong Jian Waike Za Zhi). 2006; 20(4):439-43.
Oudega M, Xu XM. Schwann Cell Transplantation for repair of the adult spinal cord. J Neurotrauma. 2006;23(3-4):453-67
