Refractory diabetic foot is one of the most serious and costly chronic complications of diabetes. It is the leading cause of nontraumatic lower-extremity amputations while the conventional treatment is not effective. Therefore, new therapeutic methods are urgently needed. Cell therapy has shown unique advantages and potential in tissue regeneration and wound repair, and is considered as a new effective method to treat diabetic foot. Meanwhile, human cord blood-derived mononuclear cells (HCB-MNCs) with its sufficient sources, strong ability of proliferation and differentiation, and weak immunogenicity, is suitable for the treatment of diabetic foot. It is a prospective, single-arm, single-center clinical study to investigate the efficacy and safety of local injection of HCB-MNCs in the treatment of refractory diabetic foot.

Start Date28 May 2023

Sponsor / Collaborator

Jiangsu Provincial People's Hospital

[+1]

NCT06427642

/ RecruitingNot Applicable

Efficacy Evaluation of Umbilical Cord Blood-derived Mononuclear Cells in the Treatment of Refractory Neonatal Diseases

Hypoxic-ischemic encephalopathy (HIE), bronchopulmonary dysplasia (BPD), short bowel syndrome (SBS) are refractory in clinical treatment. Thus, how to better prevent such diseases is currently a key research topic in the international field. The use of cord blood-derived mononuclear cells may promote to save lives and improve patient outcomes.

Start Date01 Apr 2022

Sponsor / Collaborator

Shandong Qilu Stem Cells Engineering Co. Ltd.

[+1]

100 Clinical Results associated with Human cord blood-derived mononuclear cells(Shandong Qilu Stem Cells Engineering)

100 Translational Medicine associated with Human cord blood-derived mononuclear cells(Shandong Qilu Stem Cells Engineering)

100 Patents (Medical) associated with Human cord blood-derived mononuclear cells(Shandong Qilu Stem Cells Engineering)

Literatures (Medical) associated with Human cord blood-derived mononuclear cells(Shandong Qilu Stem Cells Engineering)

17 Mar 2023·Stem Cells Translational Medicine

Factors Influencing the Efficacy of Umbilical Cord Blood-Derived Cell Therapy for Perinatal Brain Injury

Article

Author: McDonald, Courtney A ; Miller, Suzanne L ; Smith, Madeleine ; Penny, Tayla ; Jenkin, Graham ; Malhotra, Atul ; Zhou, Lindsay ; Purcell, Elisha ; Nguyen, Timothy ; Paton, Madison C B

AbstractIntroductionWe have previously described preclinical literature which supports umbilical cord blood-derived cell (UCBC) therapy as an efficacious treatment for perinatal brain injury. However, efficacy of UCBCs may be influenced by different patient population and intervention characteristics.ObjectivesTo systematically review the effects of UCBCs on brain outcomes in animal models of perinatal brain injury across subgroups to better understand the contribution of model type (preterm versus term), brain injury type, UCB cell type, route of administration, timing of intervention, cell dosage, and number of doses.MethodsA systematic search of MEDLINE and Embase databases was performed to identify studies using UCBC therapy in animal models of perinatal brain injury. Subgroup differences were measured by chi2 test where possible.ResultsDifferential benefits of UCBCs were seen across a number of subgroup analyses including intraventricular hemorrhage (IVH) vs. hypoxia ischemia (HI) model (apoptosis white matter (WM): chi2 = 4.07; P = .04, neuroinflammation-TNF-α: chi2 = 5.99; P = .01), UCB-derived mesenchymal stromal cells (MSCs) vs. UCB-derived mononuclear cells (MNCs) (oligodendrocyte WM: chi2 = 5.01; P = .03, neuroinflammation-TNF-α: chi2 = 3.93; P = .05, apoptosis grey matter (GM), astrogliosis WM), and intraventricular/intrathecal vs. systemic routes of administration (microglial activation GM: chi2 = 7.51; P = .02, astrogliosis WM: chi2 = 12.44; P = .002). We identified a serious risk of bias and overall low certainty of evidence.ConclusionsPreclinical evidence suggests UCBCs to show greater efficacy in the injury model of IVH compared to HI, the use of UCB-MSCs compared to UCB-MNCs and the use of local administrative routes compared to systemic routes in animal models of perinatal brain injury. Further research is needed to improve certainty of evidence and address knowledge gaps.

01 Dec 2022·BMC NeurologyQ4 · MEDICINE

The safety and efficacy of umbilical cord blood mononuclear cells in individuals with spastic cerebral palsy: a randomized double-blind sham-controlled clinical trial

Q4 · MEDICINE

ArticleOA

Author: Rabbani, Ali ; Nouri, Masoumeh ; Ashrafi, Mahmoud Reza ; Heidari, Morteza ; Taghdiri, Mohammad Mehdi ; Pak, Neda ; Amanat, Man ; Shodjaee, Razieh ; Shamsabadi, Farhad Mahvelati ; Masoomi, Safdar ; Mohammad, Monireh ; Ghofrani, Mohammad ; Alizadeh, Houman ; Mohamadpour, Masood ; Gholami, Mona ; Zarrabi, Morteza ; Malamiri, Reza Azizi ; Javadzadeh, Mohsen ; Mohebbi, Ali ; Hamidieh, Amir Ali ; Moaiedi, Ali Reza ; Karimi, Hossein ; Mohammadi, Mahmoud ; Noparast, Zahra ; Akbari, Masood Ghahvechi ; Rahimi-Dehgolan, Shahram ; Montazerlotfelahi, Hadi ; Rahimi, Rosa ; Valizadeh, Amir ; Dehghan, Ensieh ; Mohseni, Mohamad Javad ; Vafaei, Nahid ; Samimi, Solaleh ; Koochakzadeh, Leyli ; Zamani, Gholam Reza ; Abroun, Saeed ; Badv, Reza Shervin ; Goudarzi, Mehrdad ; Tavasoli, Ali Reza ; Vosough, Massoud ; Majmaa, Anahita ; Hassanpour, Seyed Hossein

AbstractIntroductionThe current multi-center, randomized, double-blind study was conducted among children with cerebral palsy (CP) to assess the safety and efficacy of umbilical cord blood mononuclear cell (UCB-MNC). We performed the diffusion tensor imaging to assess the changes in the white matter structure.MethodsMales and females aged 4 to 14 years old with spastic CP were included. Eligible participants were allocated in 4:1 ratio to be in the experimental or control groups; respectively. Individuals who were assigned in UCB-MNC group were tested for human leukocyte antigen (HLA) and fully-matched individuals were treated with UCB-MNCs. A single dose (5 × 106 /kg) UCB-MNCs were administered via intrathecal route in experimental group. The changes in gross motor function measure (GMFM)-66 from baseline to one year after treatment were the primary endpoints. The mean changes in modified Ashworth scale (MAS), pediatric evaluation of disability inventory (PEDI), and CP quality of life (CP-QoL) were also evaluated and compared between groups. The mean changes in fractional anisotropy (FA) and mean diffusivity (MD) of corticospinal tract (CST) and posterior thalamic radiation (PTR) were the secondary endpoints. Adverse events were safety endpoint.ResultsThere were 72 included individuals (36 cases in each group). The mean GMFM-66 scores increased in experimental group; compared to baseline (+ 9.62; 95%CI: 6.75, 12.49) and control arm (β: 7.10; 95%CI: 2.08, 12.76; Cohen’s d: 0.62) and mean MAS reduced in individuals treated with UCB-MNCs compared to the baseline (-0.87; 95%CI: -1.2, -0.54) and control group (β: -0.58; 95%CI: -1.18, -0.11; Cohen’s d: 0.36). The mean PEDI scores and mean CP-QoL scores in two domains were higher in the experimental group compared to the control. The imaging data indicated that mean FA increased and MD decreased in participants of UCB-MNC group indicating improvements in white matter structure. Lower back pain, headaches, and irritability were the most common adverse events within 24 h of treatment that were related to lumbar puncture. No side effects were observed during follow-up.ConclusionsThis trial showed that intrathecal injection of UCB-MNCs were safe and effective in children with CP.Trial RegistrationThe study was registered with ClinicalTrials.gov (NCT03795974).

01 Jan 2022·Cell Transplantation

Autologous Umbilical Cord Blood–Derived Mononuclear Cell Therapy Promotes Cardiac Proliferation and Adaptation in a Porcine Model of Right Ventricle Pressure Overload

Article

Author: Maleszewski, Joseph J. ; Kremers, Walter K. ; Cantero Peral, Susana ; Larsen, Brandon T. ; Edwards, Brooks S. ; Burkhart, Harold M. ; Holst, Kimberly A. ; Hathcock, Matthew A. ; Qureshi, Muhammad Y. ; Oommen, Saji ; Nelson, Timothy J. ; Dearani, Joseph A. ; Brandt, Emma B.

Congenital heart diseases, including single ventricle circulations, are clinically challenging due to chronic pressure overload and the inability of the myocardium to compensate for lifelong physiological demands. To determine the clinical relevance of autologous umbilical cord blood–derived mononuclear cells (UCB-MNCs) as a therapy to augment cardiac adaptation following surgical management of congenital heart disease, a validated model system of right ventricular pressure overload due to pulmonary artery banding (PAB) in juvenile pigs has been employed. PAB in a juvenile porcine model and intramyocardial delivery of UCB-MNCs was evaluated in three distinct 12-week studies utilizing serial cardiac imaging and end-of-study pathology evaluations. PAB reproducibly induced pressure overload leading to chronic right ventricular remodeling including significant myocardial fibrosis and elevation of heart failure biomarkers. High-dose UCB-MNCs (3 million/kg) delivered into the right ventricular myocardium did not cause any detectable safety issues in the context of arrhythmias or abnormal cardiac physiology. In addition, this high-dose treatment compared with placebo controls demonstrated that UCB-MNCs promoted a significant increase in Ki-67-positive cardiomyocytes coupled with an increase in the number of CD31+ endothelium. Furthermore, the incorporation of BrdU-labeled cells within the myocardium confirmed the biological potency of the high-dose UCB-MNC treatment. Finally, the cell-based treatment augmented the physiological adaptation compared with controls with a trend toward increased right ventricular mass within the 12 weeks of the follow-up period. Despite these adaptations, functional changes as measured by echocardiography and magnetic resonance imaging did not demonstrate differences between cohorts in this surgical model system. Therefore, this randomized, double-blinded, placebo-controlled pre-clinical trial establishes the safety of UCB-MNCs delivered via intramyocardial injections in a dysfunctional right ventricle and validates the induction of cardiac proliferation and angiogenesis as transient paracrine mechanisms that may be important to optimize long-term outcomes for surgically repaired congenital heart diseases.

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