Human Umbilical Cord Mesenchymal Stem Cells to Treat Neuromyelitis Optica Spectrum Disorder (hUC-MSC-NMOSD): A Study Protocol for a Prospective, Multicenter, Randomized, Placebo-Controlled Clinical Trial.

Background: Neuromyelitis Optica spectrum disorder (NMOSD) is severe relapsing and disabling autoimmune disease of the central nervous system. Its optimal first-line treatment to reduce relapse rate and ameliorate neurological disability remains unclear. We will conduct a prospective, multicenter, randomized, placebo-controlled clinical trial to study the safety and effectiveness of human umbilical cord mesenchymal stem cells (hUC-MSCs) in treating NMOSD. Methods: The trial is planned to recruit 430 AQP4-IgG seropositive NMOSD patients. It consists of three consecutive stages. The first stage will be carried out in the leading center only and aims to evaluate the safety of hUC-MSCs. Patients will be treated with three different doses of hUC-MSCs: 1, 2, or 5 × 106 MSC/kg·weight for the low-, medium-, and high-dose group, respectively. The second and third stages will be carried out in six centers. The second stage aims to find the optimal dosage. Patients will be 1:1:1:1 randomized into the low-, medium-, high-dose group and the controlled group. The third stage aims to evaluate the effectiveness. Patients will be 1:1 randomized into the optimal dose and the controlled group. The primary endpoint is the first recurrent time and secondary endpoints are the recurrent times, EDSS scores, MRI lesion numbers, OSIS scores, Hauser walking index, and SF-36 scores. Endpoint events and side effects will be evaluated every 3 months for 2 years. Discussion: Although hUC-MSC has shown promising treatment effects of NMOSD in preclinical studies, there is still a lack of well-designed clinical trials to evaluate the safety and effectiveness of hUC-MSC among NMOSD patients. As far as we know, this trial will be the first one to systematically demonstrate the clinical safety and efficacy of hUC-MSC in treating NMOSD and might be able to determine the optimal dose of hUC-MSC for NMOSD patients. Trial registration: The study was registered with the Chinese Clinical Trial Registry (CHICTR.org.cn) on 2 March 2016 (registration No. ChiCTR-INR-16008037), and the revised trial protocol (Protocol version 1.2.1) was released on 16 March 2020.

Application status of small interfering RNA in spinal cord injury / 中国组织工程研究

BACKGROUND:The connection between high-level central nervous system and spinal cord and peripheral nerve under injury level is blocked by traumatic spinal cord injury,and the whole function of the body is thereby influenced.The loss of motor function and feeling both severely affect the patient's life quality in views of physiology,psychology,function and social economics.RNA interference is an effective method to silence target genes,which provides a new treatment strategy for spinal cord injury.OBJECTIVE:To explore the application status of RNA interference in spinal cord injury.METHODS:PubMed and CNKI databases were retrieved using the keywords of "RNA interference,RNAi,spinal cord injury" in English and Chinese,respectively.The articles addressing the application of RNA interference in spinal cord injury were collected and reviewed.RESULTS AND CONCLUSION:Totally 44 articles were enrolled.It is urgent to find a new way to treat spinal cord injury.Compared with the traditional gene silencing technology,RNA interference owing to high specificity,high efficiency,high stability and high penetrability is considered to be a new direction for the studies on the pathogenesis and treatment of spinal cord injury.

Diagnosis and treatment of bone marrow edema syndrome of the hip and differential diagnosis from avascular necrosis of femoral head / 中国骨伤

<p><b>OBJECTIVE</b>To observe the diagnosis and treatment of bone marrow edema syndrome and summarize its features, mechanisms and its differences from avascular necrosis of femoral head.</p><p><b>METHODS</b>From 2004.1, 19 patients (12 patients were males and 7 patients were females, with a mean age of (46.70 +/- 10.36) years) with bone marrow edema syndrome of hip treated with Ibandronate and physical therapy, as well as scored with Harris system before and after treatment.</p><p><b>RESULTS</b>Average score before treatment was (43.17 +/- 12.62), and (86.73 +/- 14.29) after treatment, and the difference was significant (P < 0.05).</p><p><b>CONCLUSION</b>Bone marrow edema syndrome of hip is different from avascular necrosis of the hip, it is a distinct clinical entity.</p>

Clinical study on effect of Astragalus Injection and its immuno-regulation action in treating chronic aplastic anemia / 中国结合医学杂志

<p><b>OBJECTIVE</b>To observe the clinical effect of Astragalus Injection (, AI) and its immuno-regulatory action in treating chronic aplastic anemia (CAA).</p><p><b>METHODS</b>Sixty patients with CAA were randomly assigned to two groups equally, both were treated with Stanozolol three times a day, 2 mg each time through oral intake, but AI was given additionally to the patients in the treated group once a day via intravenous dripping. All were treated for 15 days as one therapeutic course and the whole medication lasted for more than 4 months totally, with follow-up adopted. The clinical efficacy was estimated and the changes of T-lymphocyte subsets in peripheral blood as well as the serum levels of tumor necrosis factor-alpha (TNF-alpha) and interleukin-2 (IL-2) were observed.</p><p><b>RESULTS</b>The total effective rate in the treated group was 83.3% (25/30), which was higher than that in the control group 66.7% (20/30), showing significant difference between them (P<0.05). Levels of hemoglobin, WBC, reticular cell and platelet were elevated in both groups after treatment, but the improvement was significantly better in the treated group than that in the control group with respect to the former three indexes (P<0.05). The level of CD4(+) increased and that of CD8(+) decreased significantly after treatment in the treated group (P<0.05), which showed significant difference as compared with those in the control group (P<0.05). Levels of serum TNF-alpha and IL-2 lowered after treatment in both groups, but significance only showed in the treated group (P<0.05). The degree of proliferation in bone marrow got raised significantly and the percentage of non-hemopoietic cells reduced significantly in the treated group after treatment, also showing significant difference to those in the control group (P<0.05).</p><p><b>CONCLUSION</b>AI could promote the recovery of hemopoietic function, which might be through improving T-lymphocyte subsets and reducing the release of negative regulatory factors such as TNF-alpha and IL-2 to alleviate the inhibition on hemopoietic function.</p>