MSC-PRODUCTS FOR CLINICAL TRIALS
OFF-THE-SHELF
READY & SIMPLE-TO-USE
READY & SIMPLE-TO-USE
FULLY GMP CONFORM PRODUCTION
WE SUPPORT ...
... the international clinicians and scientists using Mesenchymal Stromal Cells (MSC) to Ameliorate Severe Complications of inflammation-associated Diseases and which aiming to make MSC-based regenerative therapies an integral part of clinical routine, also in large patient groups and at reasonable cost.
WE PROVIDE ...
... allogeneic, off-the-shelf, ready-to-use MSC Products for Clinical Trials in adults, children and neonates for various indications based on patented isolation protocols utilizing umbilical cord tissue.
The MDTB Group is dedicated to make
MSC-based therapies available
for clinical application.
MSC ameliorate inflammation and are successfully used in different diseases.
MSC modulate hyper-inflammatory processes1-5 and thereby ameliorate inflammatory cytokine release, prevent the onset of organ injury or promote regeneration of organ damage. There are more than 80,000 publications regarding MSC. If you need further information concerning MSC and if you are member of a medical professions or institution acc. to §2 HWG (German Heilmittelwerbegesetz) please contact us [ contact-at-mdtbcells.com].
The MDTB Group embodies pharmaceutical companies for cell-based immunomodulating substances and drugs. The focus is on new therapies for serious diseases caused by an excessive immune response/ reaction, as Severe Covid-19, Severe Sepsis, Graft versus Host Disease (GvHD) and also Chronic Lung Disease (CLD).
The initial focus of MDTB Group, together with leading scientists, clinicians, patient organisations and regulatory authorities was to make Mesenchymal Stromal Cells (MSC) available for treatment of chronic lung disease of preterm infants. To solve an unmet medical need in other fatal diseases, MDTB has broadened the focus in recent years to make an effective cell-based therapy available using MSC to Ameliorate Serious Complications of Severe inflammation-associated diseases at reasonable costs.
is focused on the regulatory framework for approval of drugs based on its active substance Desacell® (Allogeneic umbilical cord tissue-derived mesenchymal stromal cells ex vivo expanded) as Advanced Therapy Medicinal Products (ATMP) in Europe, North America and other regions.
is focused on the industrial-scaled and cost-effective Good Manufacturing Practice (GMP) production of Desacell® in Germany. MDTB is a spin-off from the Center for Regenerative Therapies Dresden (CRTD), which has long-standing expertise in the production of Mesenchymal Stromal Cells (MSC), including procedures for the isolation, expansion, cryopreservation and thawing of MSC and its compassionate use in several clinical settings at the University Hospital Dresden – one of the leading hospitals in the field of regenerative therapies.
DRUG SUBSTANCE
Desacell®
MSC FOR CLINICAL APPLICATION
Available off-the-Shelf
Allogenic
[no need for HLA-matching or other compatibility testing]
High therapeutic Potential
[by young cells isolated from donated umbilical cords]
High Quantities
[billions of MSC]
Ready & simple to use
Reasonable Cost
DRUG PRODUCTS
Based on the Drug Substance Desacell®
We support you applying for grants/financing and for trial approvals, e.g. via supporting your IMPD composing.
We are able to supply increasing amounts
for your Phase-I, Phase II and Phase III-studies.
Our off-the shelf/ ready-and-simple-to-use pharmaceutical MSC-products are available.
As finished investigational drug/ investigational medicinal product (IMP) according to your IMPD or as active substance to be finished to IMP at your site/ lab
In different grades [e.g. RD-grade for preclinical use, CT-grade für clinical trials]
In different doses (millions to billions of cells)/ concentrations
In different packagings
According to different requirements of different regulatory bodies.
TEAM
MDTB is a clinically driven company. We follow a strong co-creation approach. Varied world-wide collaborations of leading scientists, clinicians and patient organisations for different indications will translate MSC-based regenerative therapies into an integral part of clinical routine.
MDTB works with Contract Manufacturing Organisations (CMO).
MDTB is supported by different regulatory partners with a dedicated experience with ATMP and MSC.
REGULATORY AND ONGOING
CLINICAL TRIALS
CLINICAL TRIALS
For any question regarding the regulatory for Descell® please contact us
[ regulatory-at-mdtbcells.com].
[ regulatory-at-mdtbcells.com].
For any question regarding ongoing clinical trials please contact us
INVESTORS
MDTB is a pharmaceutical boutique with clearly defined and structured investment cases.
MDTB offers exciting entry and exit opportunities for investors with different goals and time horizons.
MDTB offers exciting entry and exit opportunities for investors with different goals and time horizons.
For any question regarding investment aspects please contact us [investors-at-mdtbcells.com].
CONTACT