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最高研发阶段临床1/2期 |
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Evaluation of the Efficacy of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in the Treatment of Cerebral Palsy Due to Brain Hypoxia: a Phase II Randomized Clinical Trial
This clinical trial aims to evaluate the effectiveness of autologous bone marrow mononuclear cell transfusion in treating cerebral palsy caused by cerebral hypoxia.
The key questions the study seeks to answer are:
* What is the safety profile in terms of adverse events (AE) and serious adverse events (SAE) observed over the 9 months following the first transplantation?
* How does autologous bone marrow mononuclear cell (BM MNC) transplantation impact the gross motor function (GMFM-88) scores and Gross Motor Function Classification System (GMFCS) scores in children with cerebral palsy?
* How does autologous BM MNC transplantation influence muscle tone (Modified Ashworth Scale score) and hand motor function (MACS/Mini-MACS scale) in children with cerebral palsy, 9 months post the initial transplantation?
Fifty-eight selected patients, aged 1 to 10 years and diagnosed with spastic cerebral palsy due to brain hypoxia, will be randomly divided into two groups:
* Group A: will receive two BM MNC infusions with the first at baseline and the second at 6 months ± 21 days (T6) via the spinal route.
* Group B: will serve as the control group for the first 9 months. During this period, patients will not receive cell transplantation but will undergo a similar rehabilitation and medication regimen as Group A. After 9 months, Group B will receive two BM MNC infusions: the first at 9 months ± 21 days (T9) and the second at 15 months ± 21 days (T15) via the spinal route, with a follow-up at 18 months ± 21 days (T18) compared to baseline.
* Both groups: will undergo rehabilitation for 10 days per month, three times, either at rehabilitation centers or performed by a rehabilitation technician at home. After this period, continued training will be conducted by family members. The combined medication regimen will include muscle relaxants (if muscle spasticity is present), vitamins, and neuroprotective drugs (Piracetam).
Phase I Clinical Trial Evaluating the Safety and Efficacy of Point-of-care CAR-T-cell Therapy in the Treatment of Relapsed/Refractory CD19+ Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia
Brief Summary: Cluster of differentiation 19 (CD19) is expressed on B cells. CD19+ tumor cells in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia can be targeted using T cells expressing CD19-specific chimeric antigen receptor (CAR).
Objective: This study aims to evaluate the safety and efficacy of single-dose anti-CD19 CAR T-cell therapy in the treatment of relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia.
Eligibility: People aged 1 to 60 years with relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia.
Design: Phase 1 clinical trial, uncontrolled, single dose of CD19 CAR T-cells.
Evaluation of Autologous Adipose Tissue-derived Mesenchymal Stem Cell Efficacy for the Treatment of Sexual Function Impairment in Female
Hormones are a chemical substance synthesized and secreted by endocrine gland. Several vital hormones, including Mullerian hormone (AMH), follicle-stimulating hormone (FSH), and Estradiol (E2), play crucial roles in regulating female sexual function.- Hormone therapy is used to treat female hormone deficiency and results in a significant improvement, but long-term use increases cardiovascular disease or cancer risk. Other treatments do not give apparent results. Therefore, it is necessary to develop new and effective treatments to achieve the requirements of improving health in general and sexual health in particularly in women. AD-MSCs have been widely used as autologous and allogeneic stem cell sources to treat numerous disease recently, and they have been proven to be safe. The phase I trial showed that administration of autologous AD-MSCs at the dose of 1.0 x 10^6 cells/kg patient bodyweight was safe for patients with sex hormone deficiency. The therapy introduced potential improvement in sexual and general quality of life indicating by the increased FSFI. Therefore, this phase II trial to evaluate efficiency of autologous adipose tissue-derived mesenchymal stem cells therapy in treatment of female patients with sexual function impairment.
100 项与 Vinmec Research Institute of Stem Cell and Gene Technology 相关的临床结果
0 项与 Vinmec Research Institute of Stem Cell and Gene Technology 相关的专利(医药)
100 项与 Vinmec Research Institute of Stem Cell and Gene Technology 相关的药物交易
100 项与 Vinmec Research Institute of Stem Cell and Gene Technology 相关的转化医学