A Phase 1 interventional study of Alocyte low dose and Alocyte medium dose in Facet Joints; Degeneration, Back Pain and Facet Joint Pain, sponsored by Alimorad Farshchian. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Alimorad Farshchian · Phase 1, Interventional, and Treatment
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
Ghormley, in 1933, was the first to perform oblique spine radiographs to view the zygapophysial or facet joints and coin the term "facet syndrome" to refer to LBP with "sciatica" originating from the facet joints. The facet joint may be affected by systemic disease, such as rheumatoid arthritis and ankylosing spondylitis, or be site of micro traumatic fractures, such as osteoarthritis, meniscoid entrapment, synovial impingement, joint subluxation, synovial inflammation, loss of cartilage, and mechanical injury. Facetogenic pain is the result of repetitive stress and/or cumulative low-level trauma, leading to inflammation and stretching of the joint capsule.
Current treatment options for this disease are limited to symptomatic treatment, including analgesics, physiotherapy, and minimally invasive or surgical treatment (spinal fusion or non-fusion), but none of the methods addresses the underlying problem. The pathological process of intervertebral disc degeneration cannot be prevented by these therapies.
Alocyte is a cellular, minimally manipulated product derived from umbilical cord blood. Alocyte's manufacturing methodology is designed to enrich human umbilical cord plasma and human umbilical cord blood-derived mononuclear cells (hematopoietic lineage cells such as lymphocytes, monocytes, stem and progenitor cells, as well as mesenchymal stem cells) present in full-term cord blood. The final product is composed of a heterogenous population of cellular products, mainly the exosomes, cytokines, and nucleated cells.
Cytokine expression of Alocyte was fully evaluated. Alocyte showed a robust expression of RANTES, Osteopontin, and Angiostatin where the first two are stem cell repair cytokines and the latter is pro-angiogenic cytokine. Other cytokine showed moderate levels are IL-8, PDGF-BB, TIMP-1, TIMP-2, Angiopoietin-1, Angiogenin, MMP-9, Tie-2, uPAR, BDNF, TGF-ß2, GRO, IGFBP-1, IGFBP-2, IL-8, IL-12-p40, MIF, and NAP-2. Alocyte contained a variety of pro-angiogenic, immune-modulatory, anti-inflammatory, pro-metabolism, and tissue repair growth factors.
Therefore, a regenerative approach for treating Facetogenic pain will be beneficial by promoting changes in the pathogenic mechanism triggered by the cellular therapeutic product Alocyte.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →This is the only study on the registry with Alimorad Farshchian as lead sponsor.
Counted across the registry records on this site, refreshed daily.
In order to be eligible to participate in this study, all individuals must meet all of the following criteria:
Exclusion Criteria:
Subjects will receive low dose injection in a single facet joint
Drug: Alocyte low dose
Subjects will receive medium dose injections in three facet joints
Drug: Alocyte medium dose
Subjects will receive high dose injections in five facet joints
Drug: Alocyte high 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.
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.
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.
Safety of Alocyte treatment adverse events
To evaluate safety ( incident of grade 3 or 4 or treatment emergent serious adverse events) of Alocyte administered in subjects experiencing Facetogenic back pain at a low, medium and high dose.
Time frame: through study completion, an average of 13 months
Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete blood count (CBC with differential)
Time frame: at 1 month
Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete blood count (CBC with differential)
Time frame: at 3 months
Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete blood count (CBC with differential)
Time frame: at 6 months months
Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel ab tests
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete metabolic panel (CMP)
Time frame: at 1 month
Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel lab tests
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete metabolic panel (CMP)
Time frame: at 3 month
Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel lab tests
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete metabolic panel (CMP)
Time frame: at 6 month
Incidence of treatment emergent adverse events as assessed by safety coagulation panel lab tests
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test coagulation panel
Time frame: at 1 month
Incidence of treatment emergent adverse events as assessed by safety coagulation panel lab tests
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test coagulation panel
Time frame: at 3 months
Incidence of treatment emergent adverse events as assessed by safety coagulation panel lab tests
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test coagulation panel
Time frame: at 6 months
Incidence of treatment emergent adverse events as assessed by blood biomarker sample lab tests
To evaluate the incidence of treatment emergent adverse events as assessed by blood biomarker sample test C-reactive protein (CRP)
Time frame: at 1 month
Incidence of treatment emergent adverse events as assessed by blood biomarker sample lab tests
To evaluate the incidence of treatment emergent adverse events as assessed by blood biomarker sample test C-reactive protein (CRP)
Time frame: at 3 months
Incidence of treatment emergent adverse events as assessed by blood biomarker sample lab tests
To evaluate the incidence of treatment emergent adverse events as assessed by blood biomarker sample test C-reactive protein (CRP)
Time frame: at 6 months
Efficacy of Alocyte treatment as assessed by the change in Quality of Life (QoL) SF-12 questionnaire
Change from baseline in subject QoL SF-12 questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Time frame: baseline, 1 month, 3 months, 6 months, 12 months
Efficacy of Alocyte Treatment for pain management as assessed by the change in Numeric Rating Scale (NRS) pain scale
Change between baseline in pain using the Numeric Rating Scale (NRS) on a scale from 0 (equals no pain) to 10 (worst pain imaginable)
Time frame: baseline, 1 month, 3 months, 6 months, 12 months
Efficacy of Alocyte Treatment for pain as assessed by the change in the Owestry Back Pain questionnaire
Change between baseline in back pain using Oswestry Low back pain questionnaire made up of 10 questions. Each question is scored from 0-5 (minimum to maximum).
Time frame: baseline, 1 month, 3 months, 6 months, 12 months
Plan to share: No
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