15
Participants
Start Date
April 29, 2024
Primary Completion Date
October 1, 2026
Study Completion Date
October 1, 2026
Alocyte low dose
"Low dose containing 0.2 - 1.0 x 10\^11 particles and 3-10x10\^6 cell in 2mL which will be administered intra-facet into a single facet joint.~Preparation of low dose: 1ml of Alocyte will be diluted with 9ml of saline. After mixing well, only 2ml of the diluted product will be used."
Alocyte medium dose
"Medium dose containing 0.6 - 3.0 x 10\^11 particles and 9-30x10\^6 cell in 6mL which will be administered intra-facet into three facet joints delivering 2ml/facet joint.~Preparation of medium dose: 1ml of Alocyte will be diluted with 9ml of saline. After mixing well, only 6ml of the diluted product will be used."
Alocyte high dose
"High dose containing 1.0 - 5.0 x 10\^11 particles and 15-50x10\^6 cell in 10mL which will be administered intra-facet into five facet joints delivering 2ml/facet joint.~Preparation of high dose: 1ml of Alocyte will be diluted with 9ml of saline. After mixing well, 10ml of diluted product will be used."
RECRUITING
The Center for Regenerative Medicine, North Miami
Alimorad Farshchian
OTHER