Newsletter March 2012 Issue

Transcription

1 Newsletter March 2012 Issue Lighting the Way to A Cure ChinaSCINet Clinical Trials Umbilical Cord Blood Mononuclear Cell (UCBMC) Transplant Phase I/II Trial in Chronic Spinal Cord Injury (SCI) (CN102b) Since November 2010, at Queen Mary Hospital and Prince of Wales Hospital, 8 chronic SCI subjects have received UCBMC transplant above and below the injured spinal cord. Four subjects were assigned into four 4-µliter UCBMC dose group and four 8-µliter transplanted UCBMC dose group. The subjects are in follow-up assessment. Preliminary safety results indicate that none of the subjects developed any neurological loss above the injury site. The study is still open for subject recruitment. In the meantime, early four week assessment of the UCBMC trial in Kunming has showed that 16-µliter cell dose for chronic SCI subjects are safe. We are submitted to the institutional review boards (IRB) for approval to directly enroll the chronic SCI patients for combination therapy of four 16-µliter cell injections and a 6-week course of oral lithium. The study is currently still open for the subject recruitment at both Queen Mary Hospital and Prince of Wales Hospital. Further information on the trial and the criteria for patient eligibility for the study is available on UCBMC Transplant Phase I/II Trial followed by rehabilitation in Chronic SCI (CN102b KM) The phase I/II clinical trial CN102b_KM "Safety and Feasibility of Umbilical Cord Blood Cell Transplant into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Trial" was launched in September 2011 at Kunming PLA General Hospital. The trial details have been posted on In addition to the cell transplant, all subjects in Kunming would be enrolled for a 12-week course of intensive rehabilitation training. This is an open-label dose-escalating clinical trial. Till January 2012, eighteen chronic SCI subjects have received UCBMC transplant from low dose of four 4-µliter cell injections to high dose of four 16-µliters cell transplant. Early four week assessments show that none of the subjects caused neurological deficits, indicating that the UCBMC transplant is safe. The study is estimated to be completed in summer UCBMC Transplant Phase I/II Trial followed by rehabilitation in Acute and Sub-acute SCI (CN102c) In addition to test UCBMC transplant in chronic SCI, Kunming PLA General Hospital has initiated a clinical trial CN102c Safety and Effect of Lithium, Umbilical Cord Blood Cells and the Combination in the Treatment of Acute and Sub-acute Spinal Cord Injury : a Randomized, Double-Blinded Placebo-Controlled Clinical Trial in September The study is currently recruiting subject injured within 4 weeks and 16 subjects have been recruited to date. In This Issue ChinaSCINet Clinical Trials Conferences & Workshops HKSCIFund Activities Furthercoming event Support Us The trial details have been posted on This is a double-blind, randomized and controlled clinical trial. Neither the subjects nor the outcome assessors know the randomization result. 60 subjects will be randomized into one of the four groups. Group A will receive a 6-week course of oral placebo; Group B will receive a six-week course of oral lithium; Group C will receive UCBMC transplant and Group D will receive combination therapy of UCBMC and a 6-week course of oral lithium. All the subjects will enter a 12-week course of rehabilitation training after the surgical treatment. Efficacy and safety will be analyzed comparing neurological scores and functional outcomes amongst the four groups. Whether the combination therapy of the cell transplant and oral lithium will be associated with greater improvements in neurological and functional outcomes is tested in this trial. 1

2 Conferences & Workshops Investigator Meeting & Workshop on Cell-based Therapies, Apr 19, 2011 ChinaSCINet organized an investigator meeting and workshop in Hong Kong on April 19, In the investigator meeting, Prof. Waisang Poon from CUHK and Dr. Gilberto Leung from HKU introduced the CN102b protocol and shared UCBMC transplant experiences on chronic SCI patients with the group. Based on the preliminary phase II trial experiences, the Phase III multicenter trial on cord blood cell transplant and oral lithium had been delineated and discussed among the investigators. Top overseas researchers and clinicians in the field of stem cell research and regenerative medicine shared their latest results and experiences with the group. Prof. Jose Cibelli from the Michigan State University and Prof. Philip Horner from the University of Washington presented their results of using ipscs on a chronic SCI model and Prof. Stephen Davies from the University of Colorado showed the specific human astrocytes for SCI repair. Press Conference: First Clinical Trial of Combination Therapy of Umbilical Cord blood Cell and Drugs for Spinal Cord Injury, Apr 20, 2011 The UCBMC transplant in SCI clinical trial CN102b was introduced and updated to the press on April 20, The technology, HLA-matched UCBMC transplant with MRI-DTI guidance, was first conceived and used in SCI in Hong Kong by Prof. Waisang Poon from CUHK, Dr. Gilberto Leung from HKU and the ChinaSCINet. In the clinical trial participant sharing session, SCI patients were invited to share their experiences on receiving the therapy. Chong To, who was paralyzed from the waist down in a traffic accident 18 years ago, so far had not suffered any side effects. He said the therapy was a hope for him to gain some improvement. An Exchange Visit of Norwegian Researchers, Clinicians and SCI Patients in Hong Kong and Kunming on SCI clinical Trials, Oct 30 Nov 3, 2011 Researchers and clinicians from Norway have expressed interest in co-organizing a SCI clinical trial in Norway with the ChinaSCINet. A group of Norwegian researchers, clinicians and SCI patients visited Hong Kong and Kunming in late Oct In Hong Kong, the group visited the Prince of Wales Hospital, the Taipo Hospital, the Shatin Hospital and the MacLehose Medical Rehabilitation Center in order to explore the surgical and rehabilitation facilities and grading assessment involved in Hong Kong trial. The Hong Kong researchers and clinicians introduced the CN102b protocol, cell preparation and shared cell transplant experiences with the visitors. Meanwhile, Dr. Thomas Glott, the chief physician of the Sunnaas Rehabilitation Hospital and Prof. Joel Glover, the director of Norwegian Center for Stem Cell Research in the University of Oslo introduced the SCI rehabilitation services and stem cell program in Norway. During the Kunming visit, the group observed a cell transplant operation and the intensive walking program developed by the Kunming PLA General hospital. Norwegian group showed strong interest in doing the walking program and cell transplant trial. Through the visit, the ChinaSCINet is successfully bridging up the people between Norway, Hong Kong and China for the experiences and treatments in surgical and rehabilitation of SCI. 2

3 HKSCIFund Activities Fundraising Gala Dinner and TV Variety Show, Apr 20, 2011 In order to promote the awareness of SCI and to raise funds for the HKSCIFund, a Gala Dinner and Variety Show was held at ATV on April 20, The show was broadcasted at ATV on April 30, Dr. the Hon. York Chow Yat ngok, SBS, JP, Dr. the Hon. Leong Che-hung, GBS, JP, Prof. Paul Tam (Pro-Vice-Chancellor of HKU), Prof. Henry Wong (Pro-Vice-Chancellor of CUHK), Mr. Wong Ching (Asia Television Ltd.), Mr. Akihiro Nagahara (United Asia Finance Ltd), Ms. Molly Kung (Chinachem Group Ltd), Mrs. Suzanne Poon (Chairperson of HKSCIFund), Mrs. Nina Lam (Director of HKSCIFund) and Prof. Wise Young (Co-chairperson of ChinaSCINet), had consented to officiate at the ceremony. With the support of ATV, many famous artists and singers, including Ms. Chan Po Chu ( 陳 寶 珠 女 士 ) and Ms. Prudence Lau ( 劉 美 君 女 士 ), performed during the show. Moreover, Mr. Stephen Chow ( 周 星 馳 先 生 ), Mr. Jackie Cheung ( 張 學 友 先 生 ), Mr. Andy Lau ( 劉 德 華 先 生 ) and many superstars also appealed for the HKSCIFund. The gala dinner and variety show successfully raised over HK$ 7 million for the Fund in supporting research and treatment of spinal cord injuries, as well as the operation of the ChinaSCINet. "Spinal Cord Injury Awareness Day & Celebration of Difference Maker", Apr 21, 2011 "Spinal Cord Injury Awareness Day & Celebration of Difference Maker" was held on April 21, 2011 in the Shatin Jockey Club. The event was jointly organized by the HKSCIFund; the Direction Association for the Handicapped; the Hong Kong Paralympic Committee & Sports Association for the Physically Disabled; and the Hong Kong International Institute of Educational Leadership. We honorably invited the world renowned Man-in-Motion Mr. Rick Hansen, a former Chinese gymnast Ms. Sang Lan; our local celebrated life warriors: Dr. Christine Leung and Mr. So Wa Wai to share their stories of 'making a difference' to over 1,400 primary and secondary school students. This event aims to encourage and inspire our younger generations not to give up easily and promotes the following objectives: (1) to set clear goals in life; (2) to persevere in the face of adversity; (3) to make a difference; and (4) to live a meaningful life in order to educate our youngsters and students in how we should value our life and our days, and ignite their passion will make a difference to the future. The Youth Difference Makers Award (YDMA) Inspired by Rick Hansen s spirit of being a Difference Maker, the Youth Difference Makers Award (YDMA) was introduced in 2011, which is jointly organized by the HKSCIFund, the Direction Association for the Handicapped and the Hong Kong International Institute of Educational Leadership. The Award scheme aims to encourage students to lead a meaningful life by aspiring to become a Difference Maker in enhancing the lives of others, to make the world a more caring, welcoming, harmonious and better place. A press conference was successfully held on September 27, Mr. Arif Lee is designated to be the YMDA ambassador encouraging schools and students to be more aware of SCI for prevention and actively participate in the YDMA scheme. A total of 32 primary and secondary schools and over 3000 students are participating and they had organized meaningful projects to make a difference in enhancing the lives of others. 10 YDMAs will be selected and announced by 2012 March. 3

4 Rick Hansen Difference Maker Award for outstanding leadership 2011 Mrs Suzanne Poon, the Chairperson of HKSCIFund and Prof. Kwok Fai So, the Co-chairperson of ChinaSCINet, have been chosen as recipients of the Rick Hansen Difference Maker Award for outstanding leadership in the area of service above self - an international award established to recognize the extraordinary contributions in the area of accessibility and inclusion or advancing research discoveries related to spinal cord injury. Forthcoming Event The 4th International Spinal Cord Injury Treatment & Trial Symposium (ISCITT), the International Association of Neurorestoratology (IANR) V and 9th Global College Neuroprotection and Neuroregeneration (GCNN) conference will be held by the ChinaSCINet, the IANR Chinese Branch and Second Hospital of Xi an Jiaotong University on 4-7 May, 2012 in Xi an, China. The conference details and registration form are posted on website Neurorestoratology has been developed rapidly by means of axonal regeneration, neuroplasticity, neural repair and replacement, neural circuit or network construction, neuromodulation or signaling repair, neuroprostheses, neurosynaptogenesis, neurogenesis, angiogenesis and neurorehabilitation. Scientists and clinicians around the world are working on different promising treatments from which patients will benefit. At the Conference, you will hear the latest research updated from the experts in the field and benefit from their work. Global development and commercialization of cell therapies for neurodegenerative diseases particularly in spinal cord injury is accelerating. The Conference brings the Science and Business together. Biotechs and academics will gather to present the advance in clinical trials and the bench top findings, and to discuss strategies to expedite the cell therapy pathway from bench to bedside through innovation and market opportunity optimization. Workshops and round-table discussions focusing on different topics will be organized during the conference. 4

5 Support Us ChinaSCINet and HKSCIFund The China Spinal Cord Injury Network (ChinaSCINet) is the largest spinal cord injury clinical trial network in the world, comprising more than 20 leading spinal cord injury centers in Mainland China, Hong Kong and Taiwan. Aiming at accelerating movement of therapies from laboratory to clinic, it has been coordinating and sponsoring a series of clinical studies. In order to facilitate spinal cord injury research, it also organizes different scientific meetings and other activities from time to time. ChinaSCINet, the non-profit organization, was established in partnership with the Hong Kong Spinal Cord Injury Fund (HKSCIFund). ChinaSCINet and HKU-SCIFund are dedicated to running the clinical trials and to raising funds for the trials respectively. The HKSCIFund Ltd. is a registered charitable organization in Hong Kong (Registered Charity Number: ). Its function is to support ChinaSCINet. The objectives of the Fund are to advance the treatment development of spinal cord injury and related conditions through support research and clinical trials of therapies for spinal cord injury and related conditions. Our target is to raise US$2 million per year. We are seeking your help to support our clinical trials and activities, to bring hope to the spinal cord injured patients and families. Donation methods: Deposit to the HKSCIFund s Hang Seng Bank account: Send crossed cheque payable to the Hong Kong Spinal Cord Injury Fund Limited (Address: Room 803, Asia Orient Tower, 33 Lockhard Road, Wanchai, Hong Kong) Donation Hotline: (852) Tax-deductible receipts will be issued for donations over HK$100. The establishment of China Spinal Cord Injury Network is to bring promising therapies for spinal cord injury from laboratory to people ChinaSCI Net Published by: China Spinal Cord Injury Network HKSCIFund Hong Kong Spinal Cord Injury Fund Newsletter Tel: (852) Fax: (852) March 2012 Issue Rm803, 8/F., Asia Orient Tower, 33 Lockhart Road, Wanchai, Hong Kong 5