The Protocol of Estimation of the Safety and Efficiency of the Method of Transfusion of UCB Hemopoietic Cells to the Patients With Diagnosed Infantile Cerebral Palsy Depending on the Degrees of Compatibility of Donor and Recipient

Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood-onset disability.
Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in the brain.
Based on many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.
This protocol was developed based on the results of the previously approved protocol of the center NCT03826498 (Allogeneic cord blood transfusion in patients with infantile cerebral palsy), which showed high efficiency in the rehabilitation of patients. The present protocol is intended for revealing the dependence of the clinical effect on the degree of tissue compatibility of umbilical cord blood samples and the recipient

Start Date01 Sep 2019

Sponsor / Collaborator

InBio, LLC

NCT04099381

/ RecruitingPhase 1/2IIT

Protocol for Evaluating the Safety and Efficacy of Transfusion of Umbilical Cord Blood in Patients With a Diagnosis of Autism Spectrum Disorder Depending on the Degree of Tissue Compatibility of the Donor and the Recipient

Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by social interaction abnormalities, impaired verbal and non-verbal communication, and repetitive, obsessive behavior, while the therapeutic effect of current treatments remains limited progress.
The possible reason for ASD is neural hypoperfusion and immune dysregulation. The Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. In this study, the safety and efficacy of hUCB-MNCs infusion will be evaluated in patients with Autism with regarding to HLA compatibility.

Start Date10 Aug 2019

Sponsor / Collaborator

InBio, LLC

100 Clinical Results associated with Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs)(INBIO)

100 Translational Medicine associated with Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs)(INBIO)

100 Patents (Medical) associated with Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs)(INBIO)

Literatures (Medical) associated with Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs)(INBIO)

01 Dec 2021·Disease MarkersQ4 · MEDICINE

Efficacy of Human Umbilical Cord Blood-Mononuclear Cell Transplantation for MSA Treatment and Its Effects on Changes in T-Cell Subsets in Peripheral Blood and Inflammatory Factors

Q4 · MEDICINE

ArticleOA

Author: Zhao, Min ; Gong, Dianrong ; Yuan, Xiaoling ; Wang, Weifei ; Yu, Haiyan

Objective. This study is aimed at examining the efficacy of human umbilical cord blood-mononuclear cell (hUCB-MNCs) transplantation through lateral atlanto-occipital space puncture in multiple system atrophy (MSA) treatment and investigating changes in T-cell subsets in peripheral blood and inflammatory factors in patients before and after treatment. Methods. A total of 20 patients with MSA who underwent hUCB-MNC transplantation through lateral atlanto-occipital space puncture in the Liaocheng People’s Hospital were enrolled. Patients were followed up at 0, 1, 3, and 6 months after treatment, and the Unified Multiple System Atrophy Rating Scale (UMSARS) scores, TNF-α in the peripheral blood, IL-6, percentage of CD4, and CD4/CD8 ratio were evaluated and compared for each follow-up point; any adverse effects were recorded. Results. UMSARS Part I scores were

20.55 \pm 3.80

19.20 \pm 3.78

, and

19.40 \pm 4.11

, 1, 3, and 6 months, respectively, after treatment and were significantly lower as compared to that before treatment (

23.50 \pm 4.72

;

P < 0.05

). Similarly, UMSARS Part II scores 1, 3, and 6 months after treatment were

25.50 \pm 5.01

24.05 \pm 5.01

, and

24.25 \pm 5.05

, respectively, significantly lower as compared to that before treatment (

30.15 \pm 5.63

;

P < 0.05

). The IL-6 values in the peripheral blood 1, 3, and 6 months after treatment were

5.25 \pm 2.70 pg / m

2.96 \pm 1.75 pg / m

, and

3.31 \pm 1.62 pg / m

, respectively, which were significantly lower (

P < 0.05

) than that before treatment (

8.22 \pm 4.69

) pg/m. The TNF-α levels at 3 and 6 months after treatment were

13.08 \pm 6.13 pg / m

and

12.24 \pm 4.76 pg / m

, respectively, which were significantly lower than that before treatment (

22.99 \pm 13.30

;

P < 0.01

). The CD4/CD8 ratios in the peripheral blood 1, 3, and 6 months after treatment were

1.09 \pm 0.25

1.30 \pm 0.24

, and

1.43 \pm 0.22

, respectively, which were significantly different than that before treatment (

0.81 \pm 0.24

P < 0.01

). Similarly, the CD4 percentages 1, 3, and 6 months after treatment were

34.09 \pm 1.79

36.05 \pm 1.50

, and

36.47 \pm 1.47

, respectively, which were significantly different than that before treatment (

0.81 \pm 0.24

;

P < 0.01

). Conclusion. hUCB-MNC transplantation through lateral atlanto-occipital space puncture could significantly improve the symptoms and signs in patients with MSA and delay the disease progression. Thus, hUCB-MNCs may modulate immune activity and reduce the inflammatory response.

01 May 2021·The Journal of Sexual MedicineQ2 · MEDICINE

Beneficial Effects of Human Umbilical Cord Blood Mononuclear Cells on Persistent Erectile Dysfunction After Treatment of 5-Alpha Reductase Inhibitor in Rats

Q2 · MEDICINE

Article

Author: Fatma Zeynep Ozen ; Didem Yilmaz-Oral ; Omer Faruk Kirlangic ; Serap Gur ; Hasan Onur Topcu ; Bulent Ozdal ; Cetin Volkan Oztekin ; Ecem Kaya-Sezginer

BACKGROUNDEffects of human umbilical cord blood (HUCB) as a valuable source for stem cell-based therapies have not been studied in persistent post-5-alpha reductase inhibitors (5ARI) erectile dysfunction (PPED).AIMTo determine the effect of intracavernosal injection of HUCB mononuclear cells (MNCs) on ED associated with dutasteride treatment.METHODSTwenty five adult male Sprague-Dawley rats were divided into 5 groups (n = 5 per group): (i) control, (ii) 8-week dutasteride (0.5 mg/kg/day, in drinking water), (iii) 12-week dutasteride, (iv) 8-week dutasteride+HUCB-MNCs (1 × 10⁶) and (v) 12-week dutasteride+HUCB-MNCs. HUCB-MNCs were administered intracavernosally after eight weeks of dutasteride treatment. Experiments were performed at 4 weeks following the injection of HUCB-MNCs. Erectile responses and isometric tension of corpus cavernosum (CC) were measured. The protein expressions of phosphodiesterase type 5 (PDE5), endothelial nitric oxide synthase (eNOS), neuronal NOS (nNOS), hypoxia-inducible factor (HIF)-1α and smooth muscle/collagen contents in penile tissue were evaluated by Western blotting, immunohistochemistry, and Masson's trichrome staining, respectively.MAIN OUTCOMEIn vivo erectile function, in vitro relaxant and contractile responses of CC, protein expression and localization of PDE5, eNOS, nNOS, HIF-1α, and smooth muscle content in penile tissue.RESULTSErectile responses in the dutasteride-treated groups were significantly decreased compared with controls (P < .001), persisting after 4-wk of washout. HUCB-MNCs restored diminished intracavernosal pressure responses, acetylcholine-, sodium nitroprusside-, sildenafil-induced relaxations, and increased phenylephrine and electrical field stimulation (EFS)-induced contractions. Decreased EFS-induced relaxations in dutasteride-treated groups were not restored by HUCB-MNCs. Increased PDE5 and reduced nNOS expressions in dutasteride groups were restored by HUCB-MNCs in the 12-week dutasteride group. eNOS and HIF-1α protein expression and serum total and free testosterone levels were similar among groups. HUCB-MNCs reversed the decreased smooth muscle/collagen ratio in dutasteride-treated tissues. There was a significant increase in PDE5 and HIF-1α staining in 8-week dutasteride animals.CLINICAL TRANSLATIONThis study demonstrates the corrective potential of HUCB-MNCs on some persistent structural and functional deterioration caused by 5ARI treatment in rats, which may encourage further evaluation of HUCB-MNCs in men with PPED.STRENGTHS AND LIMITATIONSTherapeutic application of intracavernosal HUCB-MNCs is a novel approach for the rat model of post-5ARI ED. Lack of serum and tissue dihydrotestosterone measurements, vehicle injections and characterization of the cells remain limitations of our study.CONCLUSIONThe persistent ED after prolonged administration of dutasteride in rats is reversed by HUCB-MNC treatment, which holds promise as a realistic therapeutic modality for this type of ED. Oztekin CV, Yilmaz-Oral D, Kaya-Sezginer E, et al. Beneficial Effects of Human Umbilical Cord Blood Mononuclear Cells on Persistent Erectile Dysfunction After Treatment of 5-Alpha Reductase Inhibitor in Rats. J Sex Med 2021;18:889-899.

01 Sep 2019·LUTS: Lower Urinary Tract SymptomsQ4 · MEDICINE

Administration of human umbilical cord blood mononuclear cells restores bladder dysfunction in streptozotocin‐induced diabetic rats

Q4 · MEDICINE

Article

Author: Kaya‐Sezginer, Ecem ; Gur, Serap ; Yilmaz‐Oral, Didem

AbstractObjectiveThis study evaluated the effect of human umbilical cord blood mononuclear cells (HUCB‐MNCs) on bladder dysfunction in streptozotocin (STZ; 35 mg/kg, i.v.)‐induced diabetic rats.MethodsAdult male Sprague–Dawley rats (n = 30) were equally divided into three groups: control group, STZ‐diabetic group, and HUCB‐MNC‐treated group (1 × 106cells). HUCB‐MNCs were isolated by density gradient centrifugation from eight healthy donors and injected into the corpus cavenosum in STZ‐diabetic rats 4 weeks after the induction of diabetes. Studies were performed 4 weeks after HUCB‐MNC or vehicle injection. In vitro organ bath studies were performed on bladder strips, whereas protein expression of hypoxia‐inducible factor (HIF)‐1α, vascular endothelial growth factor (VEGF), and α‐smooth muscle actin (SMA) in the bladder and the ratio of smooth muscle cells (SMCs) to collagen were determined using western blotting and Masson trichrome staining.ResultsNeurogenic contractions of detrusor smooth muscle strips were 55% smaller in the diabetic group than control group (P < 0.05); these contractions were normalized by HUCB‐MNC treatment. In addition, HUCB‐MNC treatment restored the impaired maximal carbachol‐induced contractile response in detrusor strips in the diabetic group (29%;P < 0.05). HUCB‐MNC treatment improved the KCl‐induced contractile response in the diabetic bladder (68%;P < 0.05), but had no effect on ATP‐induced contractile responses. Increased expression of HIF‐1α and VEGF protein and decreased expression of α‐SMA protein and the SMC/collagen ratio in diabetic rats were reversed by HUCB‐MNC.ConclusionAdministration of HUCB‐MNCs facilitates bladder function recovery, which is likely related to downregulation of HIF‐1α expression and attenuation of fibrosis in STZ‐diabetic rats.

100 Deals associated with Human Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs)(INBIO)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Cerebral Palsy	Phase 2	Russia	InBio, LLC	01 Sep 2019
Autism Spectrum Disorder	Phase 2	Russia	InBio, LLC	10 Aug 2019
Autistic Disorder	Phase 2	Russia	InBio, LLC	10 Aug 2019
Heart Septal Defects, Atrial	Phase 2	Russia	InBio, LLC	10 Aug 2019

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