An Exploratory, Open Label, Multiple Dose, Multicentre Phase I/II Trial Evaluating Safety and Efficacy of Postnatal or Prenatal and Postnatal Intravenous Administration of Allogeneic Expanded Fetal Mesenchymal Stem Cells for the Treatment of Severe Osteogenesis Imperfecta Compared With a Combination of Historical and Untreated Prospective Controls

An exploratory, open label, multiple dose, multicentre phase I/II trial evaluating safety and efficacy of postnatal or prenatal and postnatal administration of allogeneic expanded fetal mesenchymal stem cells for the treatment of severe Osteogenesis Imperfecta compared with a combination of historical and untreated prospective controls.

Start Date12 Aug 2019

Sponsor / Collaborator

Karolinska Institutet

[+7]

NCT04623606 / Unknown statusPhase 1/2IIT

Exploratory, Open Label, Multiple Dose, Phase I/II Trial Evaluating Safety, Efficacy of Intravenous and Intraosseous Infusion of Allogeneic Fetal Mesenchymal Stem In Treatment of Severe Osteogenesis Imperfecta Compared With Historical and Untreated Prospective Controls

An exploratory, open label, multiple dose, phase I/II trial (n=15) evaluating safety and efficacy of intravenous and intraosseous infusion of allogeneic expanded fetal mesenchymal stem cells (MSC) for the treatment of severe Osteogenesis Imperfecta (OI) compared with historical and untreated prospective controls.

Start Date20 May 2019

Sponsor / Collaborator

Christian Medical College & Hospital

[+3]

100 Clinical Results associated with BOOST cells(Karolinska Institutet)

100 Translational Medicine associated with BOOST cells(Karolinska Institutet)

100 Patents (Medical) associated with BOOST cells(Karolinska Institutet)

Literatures (Medical) associated with BOOST cells(Karolinska Institutet)

01 Dec 2021·Nutrition & MetabolismQ3 · MEDICINE

Impact of mixed meal tolerance test composition on measures of beta-cell function in type 2 diabetes

Q3 · MEDICINE

ArticleOA

Author: Roden, Michael ; Szendroedi, Julia ; Bódis, Kálmán ; Kuss, Oliver ; Burkart, Volker ; Zaharia, Oana-Patricia ; Kössler, Theresa ; Karusheva, Yanislava ; Möser, Clara ; Strassburger, Klaus ; Bobrov, Pavel

AbstractBackgroundApplication of mixed meal tolerance tests (MMTT) to measure beta-cell function in long-term studies is limited by modification of the commercial products occurring over time. This study assessed the intra-individual reliability of MMTTs and compared the effects of liquid meals differing in macronutrient composition on the estimation of beta-cell function in type 2 diabetes (T2DM).MethodsTo test the reliability of MMTTs, 10 people with T2DM (age 58 ± 11 years, body mass index 30.0 ± 4.9 kg/m2) received Boost®high Protein 20 g protein three times. For comparing different meals, another 10 persons with T2DM (58 ± 5 years, 31.9 ± 5.3 kg/m2) ingested either Boost®high Protein 20 g protein or the isocaloric Boost®high Protein 15 g protein containing 35% less protein and 18% more carbohydrates. C-peptide, insulin and glucose release were assessed from the incremental area under the concentration time curve (iAUC) and the intra- and inter-individual variation of these parameters from the coefficients of variations (CV).ResultsRepetitive ingestion of one meal revealed intra-individual CVs for the iAUCs of C-peptide, insulin and glucose, which were at least 3-times lower than the inter-individual variation of these parameters (18.2%, 19.7% and 18.9% vs. 74.2%, 70.5% and 207.7%) indicating a good reliability. Ingestion of two different meals resulted in comparable intra-individual CVs of the iAUCs of C-peptide and insulin (16.9%, 20.5%).ConclusionMMTTs provide reliable estimation of beta-cell function in people with T2DM. Furthermore, moderate differences in the protein and carbohydrate contents in a standardized liquid meal do not result in relevant changes of C-peptide and insulin responses.Trial registration: Clinicaltrials.gov, Identifier number: NCT01055093. Registered 22 January 2010 – Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/study/NCT01055093

01 Feb 2021·European Journal of Applied PhysiologyQ3 · MEDICINE

Contractile history affects sag and boost properties of unfused tetanic contractions in human quadriceps muscles

Q3 · MEDICINE

Article

Author: Herzog, Walter ; Smith, Ian C ; Celichowski, Jan ; Kryściak, Katarzyna ; Onasch, Franziska

PURPOSEA period of extra-efficient force production ("boost") followed by a decline in force ("sag") is often observed at the onset of unfused tetanic contractions. We tested the hypothesis that in human muscle boost and sag are diminished in repeated contractions separated by short rest periods and are re-established or enhanced following long rest periods.METHODSTwo sets of 3 unfused tetanic contractions were evoked in the right quadriceps muscle group of 29 participants via percutaneous stimulation of the femoral nerve. Contractions consisted of 20 pulses evoked at inter-pulse intervals of 1.25 × twitch time to peak torque. Contractions were evoked 5 s apart and sets were evoked 5 min apart.RESULTSThe ratio of the angular impulse of pulses 1-10 to the angular impulse of pulses 11-20 was used as the boost indicator. By this metric, boost was higher (P < 0.05) in the first relative to the second and third contractions within a set, but did not differ between sets (Set 1: 1.31 ± 0.15, 1.18 ± 0.12, 1.14 ± 0.12 vs Set 2: 1.34 ± 0.17, 1.17 ± 0.13, 1.14 ± 0.13). Sag (the percent decline in torque within each contraction) was also higher (P < 0.05) in the first relative to the second and third contractions within a set, but did not differ between sets (Set 1: 40.8 ± 7.5%, 35.4 ± 6.8%, 33.2 ± 7.8% vs Set 2: 42.1 ± 8.0%, 35.5 ± 6.8%, 33.9 ± 7.2%). Participants' sex and resistance training background did not influence boost or sag.CONCLUSIONBoost and sag are sensitive to contractile history in whole human quadriceps. Optimizing boost may have application in strength and power sports.

01 Mar 2017·Alcoholism: Clinical and Experimental ResearchQ3 · MEDICINE

Voluntary Binge Consumption of Ethanol in a Sweetened, Chocolate-Flavored Solution by Male and Female Adolescent Sprague Dawley Rats

Q3 · MEDICINE

Article

Author: Hosová, Dominika ; Spear, Linda Patia

BACKGROUNDThe still maturing adolescent brain may be particularly vulnerable to lasting consequences of ethanol (EtOH) exposure. Yet, human adolescents are the age group most likely to engage in binge drinking (a pattern of drinking leading to blood EtOH concentrations (BECs) of 80 mg/dl or greater). Most studies to date assessing the long-term effects of adolescent EtOH exposure in outbred rodent populations have either used experimenter-administered EtOH to produce BECs in the binge range or assessed voluntary intake of EtOH at well below binge levels. Beginning with a modified schedule-induced polydipsia (SIP) procedure, this study examined the suitability of several approaches to induce voluntary binge-like consumption during adolescence in an outbred rat strain.METHODSAdolescent male and female Sprague Dawley rats were food deprived to 85% projected free-feeding weights beginning on postnatal day (P) 24 and were given 30 minutes of access to 10% EtOH in chocolate Boost^® or Boost^® alone daily from P28 to P41 (followed later by their daily allocation of food). Animals were tested within operant chambers (Exp. 1a, 1b and Exp. 2) or home and novel cages (Exp. 3). Animals received either scheduled delivery of banana pellets to examine SIP (Exp. 1a,b) or massed pellet presentation (Exp. 2 and Exp. 3). Blood samples were collected via the lateral tail vein on P33 and P41.RESULTSIntakes produced BECs frequently in the binge range (>80 mg/dl) and modeled binge-like consumption patterns, with high consumption days typically followed by 1 to 2 days of lower consumption; this variability was less evident with Boost^® alone. Consumption was not schedule induced and was generally high across all studies, although consumption in males appeared to be particularly pronounced when animals were tested in the presence of their cage mate.CONCLUSIONSBinge-like patterns of EtOH consumption were produced using these procedures in adolescent Sprague Dawley rats of both sexes and may prove to be a useful model for work examining the short- and long-term consequences of high levels of voluntary EtOH intake in adolescence.

100 Deals associated with BOOST cells(Karolinska Institutet)

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Indication	Highest Phase	Country/Location	Organization	Date
Osteogenesis Imperfecta	Phase 2	-	Karolinska Institutet	-

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