Table 3.
List of the Phase I/II clinical protocols ongoing or under submission conducted by the Cell Factory in cooperation with clinical groups belonging to different specialties within our hospital, or outside on a national and European basis
| Clinical protocols | Condition | Eudract number | Authorization date | Recruitment | Speciality | Number of treated patients | References |
|---|---|---|---|---|---|---|---|
| Autologous bone marrow mesenchymal stem cells for Progressive Sopranuclear Palsy patients | Parkinsonism | 2011-004051-39 | 09/24/2012 | Ongoing | Neurology | 5 | 9 |
| Allogenic cord blood mesenchymal stem cells for kidney disease | Glomerulo sclerosis | 2011-001387-21 | 11/26/2013 | Ongoing | Nephrology | 0 | NA |
| Evaluation of efficacy and safety of autologous bone marrow mesenchymal stem cells combined to biomaterials to enhance bone healing in patients with delayed consolidation after long bone fracture requiring graft apposition or alternative orthobiologics | Long bone fractures | 2011-005441-13 | 04/19/2013 | Ongoing | Orthopedics | 28a | NA |
| Allogenic cord blood mesenchymal stem cells for lung repair in neonatal pulmonary dysplasia | Neonatal pulmonary dysplasia | 2012-001456-19 | NA | Under submission | Pneumology | 0 | NA |
| Jaw bone reconstruction using a combination of autologous bone mesenchymal stem cells and biomaterial prior to dental implant placement | Jaw bone reconstruction | 2012-003139-50 | NA | Under submission | Orthopedics | 0 | NA |
| Evaluation of safety and feasibility of bone marrow derived autologous mesenchymal stem cells to enhance bone healing in patients with avascular necrosis of the femoral head | Necrosis of the femoral head | 2012-002010-39 | 12/10/2013 | Ongoing | Orthopedics | 7b | NA |
| Rationale on safety in bone marrow mesenchymal stem cell use from third party donors, in patients with avascular necrosis of the femoral head developed following stem cell transplantation | Necrosis of the femoral head | 2014-000516-34 | 06/18/2014c | Under submission | Orthopedics | 0 | NA |
| Autologous adipose-derived mesenchymal stem cells for Crohn’s disease | Crohn’s disease | NA | NA | Under submission | Inflammatory bowel disease | 0 | NA |
Notes: Information on the clinical protocols supported by the Cell Factory (updated to January 15, 2015).
a
Seven cell productions performed by the Cell Factory in Milano.
b
One cell production performed by the Cell Factory in Milano.
c
Voluntary harmonized procedure VHP466 (VHP201437) obtained on June 18, 2014 for Spain and Germany. Extension to Italy ongoing.
Abbreviation: NA, not available.