Current Clinical Trials

Heidelberg, April 2019 - RHEACELL, a subsidiary of TICEBA, is recruiting patients for two clinical trials in phase I/IIa: an international FDA approved multicenter clinical trial with allogeneic (donor-derived) ABCB5+ mesenchymal stem cells for the indication recessive dystrophic epidermolysis bullosa (RDEB) and an international and FDA approved clinical trial with allogeneic ABCB5+ limbal stem cells for the indication limbal stem cell deficiency (LSCD).

The product of RHEACELL, based on ABCB5 positive mesenchymal stem cells, has been granted the Orphan Drug Designation for the treatment of RDEB in the EU. More information can be found HERE and HERE.

The limbal stem cell product, based on ABCB5 positive stem cells, of RHEACELL has also been granted the Orphan Drug Designation in the EU and Fast Track Designation in the USA. More information can be found the following links:



RHEACELL is recruiting patients for two further clinical trials in phase I/IIa. The indications for these two clinical trials are acute-on-chronic liver failure (ACLF) to be treated with allogeneic ABCB5-positive (ABCB5+) mesenchymal stem cells and limbal stem cell deficiency (LSCD) to be treated with ABCB5+ limbal stem cells.

Heidelberg, March 2019 - Our subsidiary RHEACELL is recruiting patients for two further clinical trials in phase I/IIa: a trial with allogeneic ABCB5+ mesenchymal stem cells for the indication acute-on-chronic liver failure (ACLF) ("An interventional, single arm, multicenter, phase I/IIa clinical trial to investigate the efficacy and safety of allo-APZ2-ACLF for the treatment of acute-on-chronic liver failure") and an international and FDA approved clinical trial with allogeneic ABCB5+ limbal stem cells for the indication limbal stem cell deficiency (LSCD) to be conducted at leading sites in Germany and at Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, United States ("An interventional, open-label, multicenter phase I/IIa clinical trial to investigate the safety and efficacy of ascending doses of allogeneic ABCB5-positive limbal stem cells (LSC2) for the treatment of limbal stem cell deficiency"). The aim of the multicenter clinical trial in patients suffering from ACLF is to investigate the efficacy (by monitoring the change of the MELD score) and safety (by monitoring adverse events) of ABCB5+ MSCs. For this trial, 18 patients are recruited in Germany.

For the limbal stem cell medicinal product, LSC2, RHEACELL recently received Orphan Drug Designation status in the EU for the treatment of limbal stem cell deficiency (LSCD). More information can be found HERE and HERE.

The aim of the multicenter clinical trial in patients suffering from ACLF is to investigate the efficacy of ABCB5+ MSCs (product name: allo-APZ2-ACLF) by monitoring the change of the MELD score and the safety by monitoring adverse events. For this trial, 18 patients are recruited in Germany.

The aim of the international, multicenter clinical trial in patients suffering from LSCD is to investigate the efficacy of ABCB5+ LSCs (product name: LSC2) in terms of regeneration of an intact cornea devoid of blood vessels and safety by monitoring adverse events. For this trial, 16 patients are recruited in Germany and the USA.

For the manufacturing process of the ABCB5+ mesenchymal stem cells and ABCB5+ limbal stem cells we are using a patent hold by the Brigham and Women's Hospital, Boston/USA, and the Children's Hospital, Boston/USA, in cooperation with our scientific partner Markus Frank, MD.

More information about the trial in ACLF patients can be found HERE (ClinicalTrails.gov) or HERE (EU Clinical Trails Register). More information about the trial in LSCD patients can be found HERE (ClinicalTrials.gov).

Background information about the clinical trials can be found HERE (ACLF) and HERE (LSCD).



RHEACELL is recruiting patients with recessive dystrophic epidermolysis bullosa for a further clinical trial in phase I/IIa with allogeneic ABCB5-positive (ABCB5+) mesenchymal stem cells.

Heidelberg, November 2018 - Our subsidiary RHEACELL is recruiting patients for a further clinical trial in phase I/IIa with allogeneic ABCB5+ mesenchymal stem cells for the indication RDEB ("An interventional, multicenter, single arm, phase I/IIa clinical trial to investigate the efficacy and safety of allo-APZ2-EB on epidermolysis bullosa (EB)").

The aim of this international, multicentric clinical trial for patients suffering from RDEB is to investigate the efficacy (by monitoring the percentage change of the EBDASI score) and Safety (by monitoring adverse events) in patients with RDEB. For this trial, 18 patients are recruited in the USA, UK, Austria, and France.

For the manufacturing process of the ABCB5+ mesenchymal stem cells we are using a patent hold by the Brigham and Women's Hospital, Boston/USA, and the Children's Hospital, Boston/USA, in cooperation with our scientific partner Markus Frank, MD.

More information about the multicentric clinical trial in patients with RDEB can be found HERE (ClinicalTrails.gov) or HERE (EU Clinical Trails Register).

Background information about the clinical trial in patients with RDEB can be found HERE.



RHEACELL is recruiting patients for a further phase I/IIa clinical trial with allogeneic ABCB5-positive (ABCB5+) mesenchymal stem cells for the indication Peripheral arterial occlusive disease (PAOD).

Heidelberg, November 2017 - Our subsidiary RHEACELL is recruiting patients for a further phase I/IIa clinical trial with allogeneic ABCB5+ mesenchymal stem cells for the indication PAOD ("A randomised, placebo-controlled, double-blind, interventional, multicenter, phase I/IIa clinical trial to investigate the efficacy and safety of allo-APZ2-PAOD for the treatment of PAOD").The aim of this multicentric clinical trial for patients suffering from PAOD is to investigate the efficacy (by monitoring the wound size reduction of PAOD-related clinically relevant ulcers) and safety (by monitoring adverse events) in patients with PAOD. 76 patients are recruited for the trial in Germany.

For the manufacturing process of the ABCB5+ mesenchymal stem cells we are using a patent hold by the Brigham and Women's Hospital, Boston/USA, and the Children's Hospital, Boston/USA, in cooperation with our scientific partner Markus Frank, MD.

More information about the multicentric clinical trial in patients with PAOD can be found HERE (ClinicalTrails.gov) or HERE (EU Clinical Trails Register).

Background information about the clinical trial in patients with PAOD can be found HERE.



RHEACELL is now also authorized for further phase I/II clinical trials with allogeneic ABCB5-positive (ABCB5+) mesenchymal stem cells for the following indications: Chronic venous ulcer (CVU) and Diabetic foot ulcer (DFU).

Heidelberg, September 2017 - Besides the interventional, single arm, phase I/IIa clinical trial to investigate the efficacy and safety of autologous ABCB5+ mesenchymal stem cells (APZ2) on wound healing of chronic venous ulcer (CVU), our subsidiary RHEACELL is now authorized for further phase I/II clinical trials with allogeneic ABCB5+ mesenchymal stem cells for the indication CVU ("An interventional, single arm, multicenter, phase I/IIa clinical trial to investigate the efficacy and safety of allo-APZ2-CVU on wound healing of chronic venous ulcer (CVU)") and DFU ("An interventional, multicenter, single arm, phase I/IIa clinical trial to investigate the efficacy and safety of allo-APZ2-DFU on wound healing of diabetic neuropathic ulcer (DFU)").

The aim of these multicentric clinical trials in patients suffering from CVU and DFU is to investigate the safety of allogeneic ABCB5+ mesenchymal cells in the human body as well as their efficacy in patients with CVU and DFU. Endpoints of the trials are the percentage of reduction in wound size and the occurrence of adverse events. For each trial, 37 patients are recruited in Germany.

For the manufacturing process of the ABCB5+ mesenchymal stem cells we are using a patent hold by the Brigham and Women's Hospital, Boston/USA, and the Children's Hospital, Boston/USA, in cooperation with our scientific partner Markus Frank, MD.

  • More information about the multicentric clinical trial in patients with CVU can be found HERE (ClinicalTrails.gov) or HERE (EU Clinical Trails Register).
  • More information about the multicentric clinical trial in patients with DFU can be found HERE (ClinicalTrails.gov) or HERE (EU Clinical Trails Register).
  • Background information about the clinical trial in patients with CVU can be found HERE
  • Background information about the clinical trial in patients with DFU can be found HERE


RHEACELL is recruiting patients with the indication chronic venous ulcer (CVU) for a phase I/IIa clinical trial.

Heidelberg, April 2016 - The aim of the multicentric clinical trial is to investigate the safety of ABCB5-positive (ABCB5+) mesenchymal stem cells in the human body as well as their efficacy in patients with CVU. As endpoints of the trial, the percentage reduction in wound size and the occurrence of adverse reactions have been defined. 37 patients are recruited for the trial in Germany.

For the manufacturing process of the ABCB5+ mesenchymal stem cells we are using a patent hold by the Brigham and Women's Hospital, Boston/USA, and the Children's Hospital, Boston/USA, in cooperation with our scientific partner Markus Frank, MD.

More information about the multicentric clinical trial in patients with CVU can be found HERE (ClinicalTrials.gov) or HERE (EU Clinical Trials Register).

Background information about the clinical trial in patients with CVU can be found HERE.

« back

News
Clinical Trial - EB

The trial has been approved by the U.S. Food and Drug Administration (FDA) and the other respective competent national regulatory authorities and has recently been granted Orphan Drug Designation for the treatment of RDEB in the EU and the USA.

Clinical Trial - LSCD

For the international and FDA approved clinical trial for the limbal stem cell medicinal product LSC2 our daughter company RHEACELL recently received Orphan Drug Designation status in the EU for the treatment of limbal stem cell deficiency (LSCD) and Fast Track Designation in the USA. More information can be found HERE and HERE.

Clinical Trials

Our subsidiary RHEACELL is recruiting patients for further clinical trials in phase I/IIa with allogeneic ABCB5-positive (ABCB5+) mesenchymal stem cells for the indications chronic venous ulcers (CVU), diabetic foot ulcers (DFU), peripheral arterial occlusive disease (PAOD), epidermolysis bullosa (EB) and acute on chronic liver failure (ACLF) and with allogeneic ABCB5+ limbal stem cells for the indication limbal stem cell deficiency (LSCD). For more information click HERE.

Safety

In a comprehensive preclinical study program, safety and local tolerability of ABCB5+ MSCs following subcutaneous, intramuscular and intravenous application has been demonstrated (Tappenbeck et al., 2019).

Newsletter