Dose Escalation Pilot Study to Evaluate the Safety of Alocyte for the Treatment of Facetogenic Back Pain

PHASE1RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

April 29, 2024

Primary Completion Date

October 1, 2026

Study Completion Date

October 1, 2026

Conditions
Facet Joints; DegenerationBack PainFacet Joint Pain
Interventions
DRUG

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."

DRUG

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."

DRUG

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."

Trial Locations (1)

33161

RECRUITING

The Center for Regenerative Medicine, North Miami

All Listed Sponsors
lead

Alimorad Farshchian

OTHER