Release date: 2017-09-04
First, the US biopharmaceutical company Athersys allogeneic bone marrow stem cells MultiStem
MultiStem, a stem cell drug from Athersys, USA, is a multipotent adult progenitor cell derived from allogeneic bone marrow. It was approved by the US FDA in July 2012 for the treatment of type I mucopolysaccharidosis (MPS-I). It is expected to be approved for the treatment of acute stroke. A clinical trial of MAPC for stroke was reported in The Lancet Neurology in March 2017 [5]. Phase II clinical trials conducted at 33 medical centers in the United States and Britain from 2011 to 2015, 129 patients with moderate to severe acute stroke, intravenously entered allogeneic bone marrow-derived stem cells (MAP) or control group within 24-48 hours after onset. The number of cells is 4x108-12x108 (large dose). 80% of patients were followed up for one year, and the condition did not improve significantly within 3 months of cell therapy. However, in the one-year cell treatment period, patients in the cell-treated group showed continuous recovery, decreased degree of disability, and decreased incidence of infection [Fig. 5]. The results suggest that the therapy is safe and no significant side effects occur. Administration of MAPC stem cells within 36 hours after stroke can improve the prognosis of stroke patients by reducing the inflammatory response, the risk of serious infection, and enhancing the recovery of the body. On September 28, 2016, MAPC cells were approved by the FDA for Phase III clinical trials [6].
Figure 5. Safety and efficacy analysis of MultiStem for stroke at 3 months and one year [5]
Second, Belgium TiGenix company allogeneic adipose stem cells Cx601
TiGenix, based in Leuven, Belgium, has a heterologous adipose-derived mesenchymal stem cell (MSC) Cx601 [1] that performs well in a phase 3 clinical trial of Crohn's disease complex anal fistula. The patient's symptoms were relieved for more than 52 weeks. In September 2016, Lancet magazine [1] reported randomized, double-blind clinical phase III trials in 49 hospitals in 7 countries in Europe: 212 patients with complicated anal fistula, 107 patients receiving standard treatment, local One-time injection of 120 x 106 Cx601 cells was given, and another group of 105 patients received placebo (saline) treatment as a control group. At week 24 after stem cell treatment, intentional treatment analysis (ITT), mITT (modified intention to treat), and PP (per protocol) all showed significant statistical differences in the cell treatment group [Fig. 1]. At the 52nd week after the injection of cells, the symptom relief rate of the Cx601 group was also significantly higher than that of the control group (59.2% vs. 41.6%). Treatment side effects were similar in the two groups (20.4% in the Cx601 group and 26.5% in the control group). Cx601 cells can treat complex anal fistula caused by Crohn's disease by secreting a series of cytokines to inhibit inflammation and immune regulation. At present, TiGenix is ​​conducting a randomized, double-blind clinical Phase III trial of Cx601 [2] to obtain a marketing approval for the US FDA.
Figure 1. Intent-to-treat analysis at 24 weeks after stem cell treatment suggests a significant difference in treatment (ITT = Intertion-to-treat, mITT = modified intention to treat, PP = perprotocol) [1].
Third, the United States BrainStorm company's own bone marrow source NurOwn
Amyotrophic lateral sclerosis (also known as motor neuron disease, gradually frozen human disease, referred to as ALS) [Figure 2], up to now, the US FDA has only approved two therapeutic drugs: the first drug is Rilutek (Riluzole), Approved on December 12, 1995, the survival of patients with gradual freezing can be extended by three months. The second drug, Edaravone (pyrazolone free radical scavenger, which reduces oxidative stress), was approved by the US FDA on May 5, 2017.
Figure 2: Hawking suffers from gradual freezing
In March 2016, JAMA Neurol reported the efficacy of NurOwn®, a BrainStorm company in the United States, in the treatment of ALS [3]. NurOwn is an autologous bone marrow-derived MSC that is induced to differentiate into MSC-NTF capable of secreting neurotrophic factor (NTF) by differentiation medium in vitro. In 12 patients with stage I ALS, intramuscular injection (IM) or intra-articular injection (IT) was given. In stage II, 14 patients with ALS were given a combination of intramuscular injection and subarachnoid injection. For patients with early ALS, autologous MSC-NTF was administered once, with a cell number of 2 x 106 cells/kg (IT), and 48 x 106 cells/kg (IM). Eighty-seven months after treatment, 87% of the response, 25% of the disease was relieved, and the ALSFRS disease progression score was improved [Fig. 3], and the FVC disease progression score was also gradually improved [Fig. 3], suggesting that stem cell therapy can benefit patients, and the treatment has no obvious side effects. produce.
Figure 3. ALSFRS score and FVC score after NurOwn treatment [3]
On July 18, 2016, BrainStorm announced the results of NurOwn's Phase II clinical trial in the US (BrainStorm's website http://ir.brainstorm-cell.com/). Randomized, double-blind, controlled, multicenter clinical trials in 48 hospitals in the United States, 48 ​​patients with ALS, 36 received MSC-NTF (combined with IM+IT) and 12 served as controls [Figure 4]. The cells were injected intramuscularly and intraspinally for 6 months. It can be seen that stem cell treatment significantly delays the progression of ALS disease, the patient's symptoms are alleviated, an effective response can be produced, and the treatment is safe and has no obvious side effects. On December 19, 2016, BrainStorm Corporation of the United States announced the start of Phase III clinical trials [4].
Figure 4. NurOwn treatment of ALS response analysis [4]
references
1. Panés J, et al. Expandedallogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianalfistulas in Crohn's disease: a phase 3 randomised, double-blind controlledtrial.Lancet. 2016 Sep 24;388(10051):1281-90
2. Tigenix official website:
Http://tigenix.com/wp-content/uploads/2017/06/170613
3. Petrou P, et al. Safety and Clinical Effects of Mesenchymal Stem Cells Secreting Neurotrophic Factor Transplantation in Patients With Amyotrophic Lateral Sclerosis: Results of Phase 1/2 and 2a Clinical Trials. JAMA Neurol. 2016 Mar;73(3):337-44
4. BrainStorm's official website: http://ir.brainstorm-cell.com/
5. Hess DC, et al. Safety and efficacy of multipotent adult progenitor cells in acute ischaemic stroke (MASTERS): a randomised, double-blind, placebo-controlled, phase 2 trial. TheLancet Neurology, 2017 Mar 17
6, Athersys company's official website:
http://?ReleaseID=991195
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