Oliver Pullig

Effect of intra-articular adipose-derived mesenchymal stromal cell versus placebo injection on pain and function in patients with knee osteoarthritis: the ADIPOA2 phase 2b randomised clinical trial

Yves‐Marie Pers, Hubert Schrezenmeier, Sandrine Fleury‐Cappellesso, Ulrich Aran Nöth et autres

OBJECTIVES: This study aims to evaluate the efficacy of intra-articular autologous adipose-derived ex vivo expanded mesenchymal stromal cells (ADSC) on patient-reported outcome (pain and function) in symptomatic mild-to-moderate tibiofemoral knee osteoarthritis (OA). METHODS: cells; or saline placebo. The primary outcome was the …

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Clinical relevance of engineered cartilage maturation in a randomized multicenter trial for articular cartilage repair

Marcus Mumme, Anke Wixmerten, Alan Ivković, Giuseppe M. Peretti et autres

Cartilage lesions do not heal spontaneously and predispose to osteoarthritis. Functional cartilage tissues, engineered using autologous chondrocytes, have a therapeutic advantage over conventional cellular therapies in preclinical studies. Here, we tested whether ex vivo maturation of engineered grafts for cartilage repair leads …

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Engineered autologous nasal cartilage for repair of nasal septal perforations: a case series

Benedict Kaiser, Sylvie Miot, Anke Wixmerten, Oliver Pullig et autres

OBJECTIVE: This phase I clinical trial assessed the use of autologous nasal chondrocyte tissue-engineered cartilage (N-TEC) for functional repair of nasal septal perforations (NSP). BACKGROUND: The most widely used technique to treat NSP, namely interposition grafting with a polydioxanone (PDS) plate combined …

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Engineered Cartilage from Nasal Chondrocytes for Knee Repair: Clinical Relevance of Tissue Maturation in a Randomized, Multicenter Phase 2 Trial

Marcus Mumme, Anke Wixmerten, Alan Ivković, Giuseppe Maria Peretti et autres

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Tissue Engineering: GOOD MANUFACTURING PRACTICE-COMPLIANT CHANGE OF RAW MATERIAL IN THE MANUFACTURING PROCESS OF A CLINICALLY USED ADVANCED THERAPY MEDICINAL PRODUCT: A COMPARABILITY STUDY

Anke Wixmerten, Sylvie Miot, Patrick Bittorf, Françine Wolf et autres

Good Manufacturing Practice–compliant change of raw material in the manufacturing process of a clinically used advanced therapy medicinal product–a comparability study

Anke Wixmerten, Sylvie Miot, Patrick Bittorf, Françine Wolf et autres

The development of medicinal products often continues throughout the different phases of a clinical study and may require challenging changes in raw and starting materials at later stages. Comparability between the product properties pre- and post-change thus needs to be ensured. Here, …

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Stammzelltherapie in Deutschland

Lars Rackwitz, Oliver Pullig, Ulrich Aran Nöth

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From Single Batch to Mass Production–Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product

Sebastian Haeusner, Laura Herbst, Patrick Bittorf, Thomas Schwarz et autres

Advanced Therapy Medicinal Products (ATMP) provide promising treatment options particularly for unmet clinical needs, such as progressive and chronic diseases where currently no satisfying treatment exists. Especially from the ATMP subclass of Tissue Engineered Products (TEPs), only a few have yet been …

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Ex vivo osteochondral test system with control over cartilage defect depth – A pilot study to investigate the effect of oxygen tension and chondrocyte based treatments in chondral and full thickness defects in an organ model

A. Schwab, Alexa Buss, Oliver Pullig, Franziska Ehlicke

Cartilage defect treatment strategies are dependent on the lesion size and severity. Osteochondral explant models are a platform to test cartilage repair strategies ex vivo. Current models lack in mimicking the variety of clinically relevant defect scenarios. In this controlled laboratory study, …

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Ex vivo osteochondral test system with control over cartilage defect depth – a pilot study to investigate the effect of oxygen tension and chondrocyte-based treatments in chondral and full thickness defects in an organ model

A. Schwab, Alexa Buss, Oliver Pullig, Franziska Ehlicke

Abstract Objective Cartilage defect treatment strategies are dependent on the lesion size and severity. Osteochondral explants models are a platform to test cartilage repair strategies ex vivo . Current models lack in mimicking the variety of clinically relevant defect scenarios. In this …

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Regulatory-Compliant Validation of a Highly Sensitive qPCR for Biodistribution Assessment of Hemophilia A Patient Cells

Patrick Bittorf, Thorsten Bergmann, Simone Merlin, Cristina Olgasi et autres

The investigation of the biodistribution profile of a cell-based medicinal product is a pivotal prerequisite to allow a factual benefit-risk assessment within the non-clinical to clinical translation in product development. Here, a qPCR-based method to determine the amount of human DNA in …

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Expandierte Zellen, Knochenmark, Fettgewebe: Was ist in Deutschland und Österreich erlaubt?

Ulrich Aran Nöth, Oliver Pullig, Stefan Nehrer, Lars Rackwitz

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