Table 3 Current clinical trials transplanting stem cells into the spinal cord
Year | Location/sponsor | Cells | Indication | Delivery | Inclusion criteria | Status | References |
|---|---|---|---|---|---|---|---|
2009 | Palo Alto, CA; Atlanta, GA; Chicago, IL; Philadelphia, PA, USA (Geron Corp.) | Allogenic human ESC-derived oligodendrocytes (GRNOPC1®) | SCI | Direct single injection to the spinal cord lesion using a table-mounted syringe positioning device (2 million cells) | Adult subacute complete thoracic SCI (ASIA grade A) | FDA phase 1. Terminated | |
2010 | Atlanta, GA, USA (Neuralstem Inc.) | Allogenic human fetal spinal cord-derived spinal stem cells (NSI-566RSC) | ALS | Direct multiple injections to the ventral horn of the lumbar or cervical enlargement using a spine-mounted microinjection platform (0.5 to 1 million cells) | Adult probable or definite ALS defined according to El Escorial criteria | FDA phase 1. Recruiting | |
2011 | Irvine, CA, USA (California Stem Cell, Inc.) | Allogenic human ESC-derived motor neuron progenitor cells (MotorGraft™) | SMA | Direct multiple injections to the ventral horn of the thoracic spinal cord | Infant (age 2 to 6 months) SMA type 1 | FDA clinical hold. Reviewing IND | [15] |
2001 | Italy | Autologous human bone marrow-derived mesenchymal stem cells | ALS | Direct multiple injections to the central gray matter of the lumbar enlargement using a table-mounted injector (7 to 152 million cells) | Adult definite ALS defined according to El Escorial criteria | Phase 1. Completed | |
2011 | Zurich, Switzerland (Stem Cells Inc.) | Allogenic fetal brain-derived human central nervous system stem cells (HuCNS-SC®) | SCI | Direct multiple injections to the inferior and superior border of spinal cord lesion (20 million cells) | Adult thoracic chronic SCI (ASIA grade A, B, or C) | Swiss medic phase 1/2. Recruiting | |
2011 | Jerusalem, Israel (BrainStorm Cell Therapeutics, Ltd) | Autologous human mesenchymal bone marrow stromal cells secreting neutrotrophic factors | ALS | Early stage: multiple intramuscular injections to triceps and biceps muscles (24 million cells). Late stage: single intrathecal injection (60 million cells) | ALS disease duration <2 years; and ALS-FRS-R scale >30 (early stage) or ALS-FRS-R scale 15 to 30 (late stage) | Israel Ministry of Health phase 1/2. Recruiting | |
2011 | Houston, TX, USA (Memorial Hermann Healthcare System) | Autologous human bone marrow-derived progenitor cells | SCI | Single intravenous infusion | Children age 1 to 15 years with chronic SCI | FDA phase 1. Recruiting | |
2010 | Covington, LA, USA (TCA Cellular Therapy, LLC) | Autologous human bone marrow-derived mesenchymal stem cells | ALS | Single intrathecal infusion | Moderate to severe ALS with El Escorial criteria | FDA phase 1. Ongoing | |
2010 | Covington, LA, USA (TCA Cellular Therapy, LLC) | Autologous human bone marrow-derived mesenchymal stem cells | SCI | Single intrathecal infusion | Subacute complete SCI below C-5 (ASIA grade A) | FDA phase 1. Ongoing | |
2010 | Rochester, MN, USA (Mayo Clinic) | Autologous human adipose tissue-derived mesenchymal stem cells | ALS | Single intrathecal infusion (1 million cells) | Adult with chronic onset of a progressive motor weakness | FDA phase 1. Ongoing | ID# NCT01142856 [11] |
2000 | Israel and Belgium (Proneuron Biotech) | Autologous human macrophages | SCI | Direct multiple hand-held injections at the caudal border of the spinal cord lesion (4 million cells) | Adult acute complete SCI between C5 and T11 (ASIA grade A) | Phase 1. Suspended | ID# NCT00073853 [11] |
2006 | Jerusalem, Israel (Hadassah Medical Organization) | Autologous human bone marrow-derived mesenchymal stem cells | MS | Intrathecal infusion of 60 million cells and intravenous infusion of 20 million cells | Definite MS | Israel Ministry of Health phase 1/2. Status unknown | ID# NCT00781872 [11] |