Facet Joints; DegenerationPhase 1NCT05909709
Dose Escalation Pilot Study to Evaluate the Safety of Alocyte for the Treatment of Facetogenic Back Pain
A Phase 1 study testing Alocyte low dose, Alocyte medium dose and Alocyte high dose in people with Facet Joints; Degeneration and Back Pain, run by Alimorad Farshchian at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facet Joints; Degeneration, Back Pain, Facet Joint Pain
- What is being tested?
- Alocyte low dose, Alocyte medium dose and Alocyte high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 1 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, all individuals must meet all of the following criteria:
- Subjects age > 18 years at the time of signing the Informed Consent Form.
- Male or Female.
- Ability of participant to understand and the willingness to sign a written informed consent document.
- Facetogenic back pain diagnosed using the following diagnostic criteria Subjects who have chronic low back pain based on clinical evaluation. Pain onset at dorsal extension and release at flexion is often considered suggestive for facet pain, even if non-specific, such as maximal tenderness upon deep palpation of posterior elements.
- Patient with up to 5 diseased facet joints
Show all 10Show fewer
- Chronic Facetogenic pain (≥ 6 months) in patients that have failed conservative management
- Subjects must be reasonably able to return for multiple follow-up visits.
- For Women of Child-Bearing Potential (WOCBP) only, willingness to use FDA-recommended birth control until 6 months post treatment.
- Any male subject must agree to use contraceptives and not donate sperm during the study.
Who cannot join
- Previous surgical intervention for back pain
- Previous stem cell injection(s) within the last year
- Use of anticoagulation or NSAIDs within 5 days of the injection
- MRI finding of severe high-grade lumbar stenosis
- Leg pain exceeding back pain
- Pain worse with flexion maneuvers
Show all 30Show fewer
- Fracture of lumbar vertebrae
- Inability to perform any of the assessments required for endpoint analysis.
- Clinically significant abnormal screening laboratory or clinical assessment values
- Use of medications during the early phase of treatment such as chronic narcotic use, systemic corticosteroid administration, local corticosteroid injection at facets anticoagulant therapy and viscosupplementation into facets, any investigational drug used within 3 months prior to screening or during study and surgery in the facets
- Subjects with serious co-morbidities are excluded.
- Evidence of inflammatory arthritis (example, rheumatoid arthritis and ankylosing spondylitis) or traumatic fractures, osteoarthritis, meniscoid entrapment, synovial impingement, joint subluxation, synovial inflammation, loss of cartilage, and mechanical injury.
- Have a clinical history of malignancy within 5 years (i.e., subjects with prior malignancy must be disease free for 5 years), except curatively treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma, if recurrence occurs.
- Be currently participating (or participated within the previous 6 months) in an investigational therapeutic or device trial.
- Exhibiting signs of moderate or severe chronic respiratory disease (such as COPD, asthma, or pulmonary fibrosis).
- Patient with rheumatologic disorders.
- History of chronic liver disease or patient showing signs of clinical jaundice at the time of screening.
- History of severe chronic kidney disease or requiring dialysis.
- Patient with NYHA Class III or IV congestive heart failure or life-threatening arrhythmias.
- Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as prior to the treatment.
- Any unstable condition of clinical significance, e.g., uncontrolled hypertension, unstable angina pectoris, worsening asthma.
- Hydroxychloroquine, oral or parenteral corticosteroids, immunosuppressants, or immunomodulating agents within 21 days prior to the Day 0/treatment visit.
- Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood pregnancy test at screening which will be within 72 hours of the IP infusion.
- Subject has a body mass index (BMI) greater than 42 kg/m2
- Subject has or had an active infection requiring systemic antibiotics within 12 weeks of enrollment in the study
- Inability to perform any of the assessments required for endpoint analysis.
- Active listing (or expected future listing) for transplant of any organ.
- Be a solid organ transplant recipient. This does not include prior cell-based therapy (>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting. Have a history of organ or cell transplant rejection.
- History of drug abuse (illegal "street" drugs except marijuana, if it is legal to use in states where patient resides), or prescription medications not being used appropriately for a pre-existing medical condition or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months
- Patients with untreated HIV infection. However, patients can be enrolled if have been treated for HIV and the test negative for HIV viral load but still test positive for antibodies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Center for Regenerative Medicine
North Miami, Florida, 33161
Ileana Simon, RN, 305-891-4686, ileana@genorthix.com
Alimorad (AJ) Farschian, genorthix@yahoo.com
About this study
Official title: An Open Label Dose Escalation Pilot Study to Evaluate the Safety of Alocyte Delivered Via Intra-articular Facet Injection for the Treatment of Facetogenic Back Pain
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
Read the detailed description
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.
- Conditions
- Facet Joints; Degeneration, Back Pain, Facet Joint Pain
- Being tested
- Alocyte low dose, Alocyte medium dose, Alocyte high dose
- Keywords
- Back pain, Facet joint pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alocyte low doseDrug
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 doseDrug
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 doseDrug
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 group | Role | What they receive |
|---|---|---|
| Alocyte Low dose | Experimental | Subjects will receive low dose injection in a single facet joint Receives: Drug: Alocyte low dose |
| Alocyte Medium dose | Experimental | Subjects will receive medium dose injections in three facet joints Receives: Drug: Alocyte medium dose |
| Alocyte High dose | Experimental | Subjects will receive high dose injections in five facet joints Receives: Drug: Alocyte high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: at 6 months
Secondary outcomes (3)
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
Measured: 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)
Measured: 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).
Measured: baseline, 1 month, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start29 Apr 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joints; DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alimorad Farshchian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alimorad Farshchian, The Center For Regenerative Medicine Laboratories
- Investigators
- Alimorad Farshchian, MD, Principal investigator, The Center For Regenerative Medicine Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909709
- Sponsor's protocol ID
- 00070133
- Status last verified
- Jan 2026
- First submitted
- 25 May 2023
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Dose Escalation Pilot Study to Evaluate the Safety of Alocyte Delivered Via Intra-articular Facet Injection for the Treatment of Facetogenic Back Pain
- ClinicalTrials.gov ID
- NCT05909709
- Acronym / sponsor ID
- 00070133
- Conditions
- Facet Joints; Degeneration, Back Pain, Facet Joint Pain
- Keywords
- Back pain, Facet joint pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Alimorad FarshchianUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alocyte Low dose | Experimental | Drug: Alocyte low doseSubjects will receive low dose injection in a single facet joint |
| Alocyte Medium dose | Experimental | Drug: Alocyte medium doseSubjects will receive medium dose injections in three facet joints |
| Alocyte High dose | Experimental | Drug: Alocyte high doseSubjects will receive high dose injections in five facet joints |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- In order to be eligible to participate in this study, all individuals must meet all of the following criteria:
Key exclusion criteria (30 listed)
- Previous surgical intervention for back pain
- Previous stem cell injection(s) within the last year
- Use of anticoagulation or NSAIDs within 5 days of the injection
- MRI finding of severe high-grade lumbar stenosis
- Leg pain exceeding back pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alocyte low doseLow 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 Low dose |
| Alocyte medium doseMedium 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 Medium dose |
| Alocyte high doseHigh 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. | Drug | Alocyte High dose |
Primary outcome
Safety of Alocyte treatment adverse events
Time frame: through study completion, an average of 13 months
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.
Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests
Time frame: at 1 month
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete blood count (CBC with differential)
Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests
Time frame: at 3 months
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete blood count (CBC with differential)
Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests
Time frame: at 6 months months
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete blood count (CBC with differential)
Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel ab tests
Time frame: at 1 month
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete metabolic panel (CMP)
Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel lab tests
Time frame: at 3 month
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete metabolic panel (CMP)
Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel lab tests
Time frame: at 6 month
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete metabolic panel (CMP)
Incidence of treatment emergent adverse events as assessed by safety coagulation panel lab tests
Time frame: at 1 month
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test coagulation panel
Incidence of treatment emergent adverse events as assessed by safety coagulation panel lab tests
Time frame: at 3 months
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test coagulation panel
Incidence of treatment emergent adverse events as assessed by safety coagulation panel lab tests
Time frame: at 6 months
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test coagulation panel
Incidence of treatment emergent adverse events as assessed by blood biomarker sample lab tests
Time frame: at 1 month
To evaluate the incidence of treatment emergent adverse events as assessed by blood biomarker sample test C-reactive protein (CRP)
Incidence of treatment emergent adverse events as assessed by blood biomarker sample lab tests
Time frame: at 3 months
To evaluate the incidence of treatment emergent adverse events as assessed by blood biomarker sample test C-reactive protein (CRP)
Incidence of treatment emergent adverse events as assessed by blood biomarker sample lab tests
Time frame: at 6 months
To evaluate the incidence of treatment emergent adverse events as assessed by blood biomarker sample test C-reactive protein (CRP)
3 secondary outcomes
Efficacy of Alocyte treatment as assessed by the change in Quality of Life (QoL) SF-12 questionnaire
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
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
Time frame: baseline, 1 month, 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Association of Subcutaneous Fat Index, Paraspinal Muscle Characteristics, and Facet Morphology With Lumbar Facet Joint Degeneration
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Not yet recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alimorad Farshchian, MD principal investigator
The Center For Regenerative Medicine Laboratories
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alocyte low dose, Alocyte medium dose and Alocyte high dose in people with Facet Joints; Degeneration and Back Pain, run by Alimorad Farshchian at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ileana Simon, RN (3058914686, ileana@genorthix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Alocyte treatment adverse events (time frame: through study completion, an average of 13 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.