Current Clinical Trials

We are now also recuiting patients for a further clinical study in phase I/IIa with allogeneic ABCB5-positive (ABCB5+) mesenchymal stem cells for the following indication: peripheral arterial occlusive disease (PAOD).

Heidelberg, November 2017 - We are now also recruiting patients for a further clinical study in phase I/IIa with allogeneic ABCB5+ mesenchymal stem cells with the indication PAOD  (“A randomised, placebo-controlled, double-blind, interventional, multicenter, phase I/IIa clinical trial to investigate the efficacy and safety of allogeneic mesenchymal ABCB5+ stem cells for the treatment of PAOD”).

The aim of the 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) of patients with PAOD. 76 patients are recruited for the trial in Germany.

We are using the patent from Brigham and Women's Hospital, Boston / USA and the Children's Hospital, Boston / USA and from Children's Hospital, Boston / USA together with our scientific partner Prof. M. Frank for the manufacturing process of the ABCB5+ mesenchymal stem cells.


Multicentric clinical trial for patients suffering from PAOD - find more information

For more information on our clinical studies click HERE.


We are now also authorized for further clinical studies in phase I/IIa 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 study to investigate the efficacy and safety of autologous APZ2 (ABCB5+ mesenchymal stem cells) on wound healing of chronic venous ulcer (CVU), which is conducted in cooperation with our subsidiary RHEACELL, we are now authorized for further clinical studies in phase I/IIa with allogeneic ABCB5+ mesenchymal stem cells with 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 the multicentric clinical trials for patients suffering from CVU and DFU is to investigate the safety of allogeneic ABCB5+ cells in the human body, as well as its efficacy in patients with CVU/DFU. The percentage of reduction in wound size and the occurrence of adverse events have been defined as endpoints of the trial. 37 patients are recruited for each trial in Germany.

  • Background information on the study for patients suffering from CVU can be found HERE.
  • Background information on the study for patients suffering from DFU can be found HERE.

We are using the patent from Brigham and Women's Hospital, Boston / USA and the Children's Hospital, Boston / USA and from Children's Hospital, Boston / USA together with our scientific partner Prof. M. Frank for the manufacturing process of the ABCB5+ mesenchymal stem cells.

Multicentric clinical trial for patients suffering from CVU - find more information

Multicentric clinical trial for patients suffering from DFU - find more information

For more information on our clinical studies click HERE.

 

The recruitment process for patients with the indication chronic venous ulcer (CVU) for the clinical trial in phase 1/2a started now.

Heidelberg, April 2016 - The aim of the multicentric clinical trial is to investigate the compatibility of ABCB5-positive (ABCB5+) cells in the human body, as well as its 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. Therefore, we use the patent from Brigham and Women´s Hospital, Boston / USA and the Children's Hospital, Boston / USA. Scientific partners are Harvard Medical School, Boston / USA, Prof. M. Frank. Clinical partners are  The University of Ulm, Germany, Department of Dermatology and Allergology and the University Hospital Würzburg, Germany, Department of General and Visceral Surgery, Vascular and Pediatric Surgery and Department of Dermatology, Venereology and Allergology.

Find more information HERE (ClinicalTrials.gov) or HERE (EU Clinical Trials Register).

Background information on the study can be found HERE.

 

« back

News
Clinical Trials

We are now also recruiting patients for further clinical studies in phase I/IIa with allogeneic ABCB5-positive (ABCB5+) mesenchymal stem cells for the following indications: chronic venous ulcer (CVU), diabetic foot ulcer (DFU) and peripheral arterial occlusive disease (PAOD). For more information click HERE.

License

Besides the authorization to manufacture a human medicinal product in accordance with § 13 (1) of the German Medicinal Products Act (AMG) for autologous mesenchymal stem cells, TICEBA is also authorized to manufacture a medicinal product for allogeneic mesenchymal as well as allogeneic limbal ABCB5 + stem cells following a recent extension. For more information click HERE.

The Story of Stem Cells

Review our category "The Story of Stem Cells" with the newest topic "Stem cells in wound healing" HERE.

Newsletter