BrainRepair UG

Brain damage in newborns - unique index discovered / Head circumference determines brain damage in newborns!

Bochum (ots) - RUB-Medics: "The risk for white matter brain damage is increased tenfold in term-born neonates with large head circumference - despite full vitality" Bochum's medics have discovered a unique method to detect babies at high-risk for white matter brain damage, a prime factor causing cerebral palsy in childhood. They prospectively screened 4,725 term-born infants by cranial ultrasound, a population that usually is not examined, and revealed that a large head circumference at birth (>90th centile) increases the risk for brain damage tenfold. This clarifies a hitherto unexplained phenomenon. "For us, white matter damage in a seemingly healthy population of largely male term-born neonates appears to be the missing link between the insult that escapes diagnosis and the development of unexplained cerebral palsy in childhood", says Prof. Dr. Arne Jensen of the Campus Clinic Gynaecology at the Ruhr-University Bochum. Together with his colleague Bert Holmer, MD, he reports in the journal "Obstetrics and Gynecology International" https://www.hindawi.com/journals/ogi/2018/2120835/.

 

Fig. 1: Head imaging (MRI) at 7 years of age. Depression of the brain during birth (Arrow) due to large head circumference (> 90th centile) and narrow birth canal (cephalo-pelvic disproportion) (Jensen and Hamelmann 2016, http://dx.doi.org/10.1155/2016/1717426).

 

Efficacy of Cord Blood Stem Cell Treatment to Improve Motor Function in 36 Infants

Fig. 1: Improvements over time after treatment of cerebral palsy (Level V – Level I) using cord blood mononuclear cells in two randomized placebo controlled double blind studies (S; K) and four case reports (P1 and P2; J1 and J2). o—o S: Mean of Gross Motor Function Measure-66 (GMFM-66) results from a randomized controlled double blind cross-over trial on treatment with autologous cord blood mononuclear cells in children suffering from cerebral palsy. Note, that the results from doses <19.8 million cells/kg body weight vs >19.8 million cells/kg body weight have been depicted (n=63; 1 - 6 years) (Sun et al., 2015 [29].  o—o K:  Mean of Gross Motor Function Classification System (GMFCS) results from a randomized controlled double blind trial on treatment with allogeneic cord blood mononuclear cells in children suffering from cerebral palsy (n=34; 6 months - 20 years) (Kang et al., 2015 [31]. +—+ P1 and P2: GMFCS results from two case reports on treatment with autologous cord blood mononuclear cells combined with G-CSF in children suffering from cerebral palsy (Papadopoulos et al., 2011 [23]). +—+ J1 and J2: Results from two case reports on treatment with autologous cord blood mononuclear cells in children suffering from cerebral palsy. In J1 the child suffered from massive global hypoxic-ischaemia after cardiac arrest at 2.5 years of age followed by quadriplegia and persistent vegetative state. At 1 year post-treatment, supported walking was possible and at 4.5 years post-treatment he entered primary school, attends now 4th grade (2017) and is able to walk freely, only supported by the arm of his mother (Jensen 2011 [10]; Jensen et al., 2013 [11]. In J2 the child suffered from hemiplegia caused by a traumatic ischaemic arterial stroke due to cephalic moulding during birth. The girl was treated at 5 years of age and is now performing city runs (3 km) without orthosis, earned a lifeguard certificate in swimming and diving (DLRG, gold badge), and plays piano using her affected hand (Jensen et al., 2016 [33]). The figure is adapted from Rosenbaum et al., 2002 [43].

Infants need help - BrainRepair by own (autologous) cord blood stem cells

The reason for writing these lines is that we have developed a truly unique treatment for brain damage/cerebral palsy in newborn infants, a condition for which there is no treatment hitherto beyond supportive and occupational care. The treatment is based on autologous (own) cord blood stem cells and therefore has virtually no adverse effects (adult stem cells). The amazing therapeutic effect can be viewed in a video taken before and after treatment along with videos of the overt massive damage in MRI examinations (http://stop-cp.org/videos/). This boy has recovered to such an extent that he is successfully attending primary school today.

Literature:

http://www.campus-klinik-bochum.de/pdf/Jensenrm12011.pdf https://www.hindawi.com/journals/ogi/2014/976321/ https://www.hindawi.com/journals/crit/2016/1717426/ https://www.hindawi.com/journals/ogi/2018/2120835/

Importantly, the European Medicinal Agency EMA has granted us the worldwide first two 'Orphan Medicinal Product Designations' for our ready-to-use product so that we actually would be in a position to enter the market after our planned trial, to make this treatment option available for all newborns in need, i.e., for 30,000 infants per year in all EU member states. This sheer number of infants reflects the magnitude of the personal, medical, and socioeconomic burden of this brain disorder and the overt unmet therapeutic needs of the paediatric population.

EMA:

https://www.ema.europa.eu/medicines/human/orphan-designations/eu3161744 https://www.ema.europa.eu/medicines/human/orphan-designations/eu3161743

Given this background and the fact that with market authorisation a market exclusivity (monopoly) will be granted for 12 years in the EU, we do not quite understand as to why it seems difficult to raise funds in the order of Euro 5 million to finance our trial as last step before entering the market which has a potential of 1 bn and is highly attractive for investors.

As an obstetrician and father it is unbearable for me to know that every month 2,500 infants with brain damage in need of curative treatment are born in the EU without us being able to help due to lack of funds and in spite of our 'Seal of Excellence' that we have been awarded by the European Commissin twice in the H2020 procedure.

Thank you for your consideration,

Arne Jensen | CEO Founder - BrainRepair UG, Germany

Growth variables and brain damage at birth predict developmental disability at four years of age

Arne JENSEN, MD, Gerhard NEUHÄUSER, MD, and Kai-Ole JENSEN, MD

Abstract

Background: Infantile brain damage and dysfunction are prime risk factors for developmental delay and Cerebral palsy in childhood that may affect school performance and educational success. Prediction of developmental performance would improve current preschool support strategies.

Objective: To explore both the effects of perinatal brain damage on psychomotor development (PMD) and the predictive capacity of birth variables on poor performance at four years of preschool age.

Methods: At 4.3(SD0.8) years, we examined the PMD of 137 newborns (61 preterm, 28-37 weeks gestation (WG) and 76 term-born infants, 38-43 WG) that were screened prospectively for Peri-/intraventricular hemorrhage (PIVH) grade 1-4 and White matter damage (WMD) using cranial ultrasound at 1-30 days after birth. We compared the results of 72 newborns with PIVH to 65 controls (no PIVH) in a matched-pair design, employing parametric and non-parametric statistical procedures, Odds ratios, and ROC curves. Relevant predictors for psychomotor performance based on IQ test (IQ), Maze test (MT), and Neurologic examination optimality score (NOS) were determined by stepwise linear regression to generate a Total Psychomotor development score (TPMDS), Morphometric vitality index (MVI), and Developmental disability index (DDI).

Results: Perinatal PIVH negatively affected MT(p<0.003) and NOS(p<0.001) but not IQ while WMD did so in all three domains of PMD. There was a decrease in TPMDS with increasing degree of PIVH(0-4) as compared with term-born controls (p<0.001). Growth retardation as assessed by Brain-body-weight and Weight/length ratios revealed a pattern of PMD that was unrelated to brain damage, reducing IQ while MT and NOS were unaffected. Preterm birth reduced all three PMD domains. TPMDS(p<0.001), MVI(p<0.001), and DDI(p<0.001) had a clear predictive capacity for PMD performance at four years age.

Conclusion: The proposed indices TPMDS, MVI, and DDI predict PMD at preschool age and allow for individualized support of children to improve school performance and educational success.