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

Part of paid clinical trials in North Miami, Florida.

Sponsor
Alimorad Farshchian
Study ID
NCT05909709
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Back Pain
  • Facet Joint Pain
  • Facet Joints; Degeneration

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alocyte low dose — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

The purpose of this study is to see if the use of Alocyte (cord blood plasma plus mononucleic cells) will be safe, well tolerated, and whether it causes any side effects. The study will also examine if the use of the Investigational Product (IP) is able to reduce local inflammation or alleviate Facetogenic back pain

Key Dates

Start date
Apr 29, 2024
Status verified
Jan 2026
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Alocyte Low dose
    Subjects will receive low dose injection in a single facet joint
  • Experimental: Alocyte Medium dose
    Subjects will receive medium dose injections in three facet joints
  • Experimental: Alocyte High dose
    Subjects will receive high dose injections in five facet joints

Primary Outcome Measure

Safety of Alocyte treatment adverse events [ Time Frame: through study completion, an average of 13 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Center for Regenerative MedicineNorth MiamiFlorida33161
Ileana Simon, RN
[email protected]
305-891-4686
Alimorad (AJ) Farschian
[email protected]
Alimorad (AJ) Farschian, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The Center for Regenerative Medicine· North Miami, FL

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