Beike Biotechnology Co., Ltd. today announced that a team led by Dr. Yang Xiaofeng at its collaborating hospital in Shenyang completed a study to assess clinical efficacy, safety, and feasibility of transplantation of peripheral blood stem cells for patients with peripheral vascular disease of the lower extremities.
Beike is best known for its research and treatments for ataxia, cerebral palsy, spinal cord injury and MS which are often covered by China Stem Cell News (http://www.stemcellschina.com), a leading stem cell news site. However, Beike also has broad experience in research and treating vascular diseases with adult stem cells mostly through its collaboration with Shenyang 463 hospital.
A total of 152 patients with peripheral vascular disease of the lower extremities were enrolled into this non-controlled study from November 2003 to March 2006. The results were published in the Journal of Geriatric Cardiology which publishes original peer-reviewed clinical and experimental reports on all aspects of cardiovascular disease in the elderly.
A second study was completed during the same period comparing the relative improvement of lower limb ischemia (lack of blood supply) between transplantation of autologous peripheral blood stem cells and transplantation of bone marrow stem cells. The study is awaiting publication in a peer- reviewed journal.
At 12 weeks, primary symptoms, including lower limb pain and coldness, were significantly improved in 137 (90.1%) of the patients; limb ulcers improved or healed in 46 (86.8%) of the 53 patients, while 25 of the 48 (47.9%) patients with limb gangrene remained steady or improved. Angiography (an X-ray) before treatment, and at 12 weeks after treatment, was performed in 10 of the patients and showed formation of new collateral vessels.
The patients had no severe adverse effects or complications related to cell transplantation.
“These preliminary results, while encouraging, must be further researched in future controlled studies and reinforced by separate studies by other laboratories,” said Yang Xiao Feng, Director of the Stem Cell Program for Vascular Diseases at Shenyang 463 Hospital.
The study followed previous studies done in the laboratory and pre- clinical work done in rabbits.
“There is evidence demonstrating significant improvement in the quality of life of patients receiving the treatment, including formation of new collateral vessels,” said Sean Hu, Chairman of Beike Biotechnology group. “We are now working to collaborate with institutions in the U.S. to further substantiate this and other studies including those we are doing for neurological diseases using umbilical cord stem cells.”
In 2006, Beike Biotechnology completed two studies involving eight patients with ALS. Two papers were published in the Journal of Zhenghou University of Medical Science. The first observed the effect of transplantation of umbilical cord blood mesenchymal stem cells (UCB-MSCs) on glutamate (Glu) levels in plasma and CSF of amyotrophic lateral sclerosis patients and the second observed the effect of umbilical cord blood mesenchymal stem cell transplantation on nervous system function of ALS patients.