Actively Recruiting
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
Led by Alimorad Farshchian · Updated on 2026-01-13
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and tolerability of Alocyte, a product derived from umbilical cord blood plasma and mononuclear cells, in treating facetogenic back pain. The study will also investigate whether Alocyte can reduce local inflammation and relieve pain caused by degenerative changes in the facet joints. Facetogenic pain results from repetitive stress and low-level trauma leading to joint inflammation, and current treatments do not address the underlying cause of this condition. Participants will receive one of three doses of Alocyte injected directly into the facet joints of the spine. The low dose is administered into a single joint, the medium dose into three joints, and the high dose into five joints, with each injection delivering a diluted preparation of the product. This open-label pilot study involves dose escalation to assess safety at varying levels of administration. During the study, participants will have multiple follow-up visits over an average of 13 months. Researchers will monitor safety through blood tests including complete blood counts, metabolic panels, coagulation panels, and biomarker analyses at 1, 3, and 6 months after treatment. They will also assess pain levels and quality of life using standardized questionnaires at baseline and throughout the follow-up period. The study focuses on observing any side effects and changes in participants' pain and function.
CONDITIONS
Brief Title
Dose Escalation Pilot Study to Evaluate the Safety of Alocyte for the Treatment of Facetogenic Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years at the time of informed consent
- Male or female participants
- Ability and willingness to sign informed consent
- Diagnosed with facetogenic back pain based on clinical evaluation
- Up to 5 diseased facet joints
- Chronic facetogenic pain lasting 6 months or more
- Failed conservative management for back pain
- Able to return for multiple follow-up visits
- Women of childbearing potential must use FDA-recommended birth control until 6 months post treatment
- Male participants must agree to use contraceptives and not donate sperm during the study
You will not qualify if you...
- Previous surgical intervention for back pain
- Stem cell injections within the past year
- Use of anticoagulants or NSAIDs within 5 days before injection
- MRI showing severe high-grade lumbar stenosis
- Leg pain more severe than back pain
- Pain worsens with flexion movements
- Fracture of lumbar vertebrae
- Unable to perform required assessments
- Abnormal clinical or laboratory screening results
- Use of certain medications including chronic narcotics, corticosteroids, anticoagulants, or investigational drugs within specified timeframes
- Serious co-morbid conditions
- Inflammatory arthritis or traumatic fractures affecting the facet joints
- History of malignancy within 5 years except certain skin or cervical cancers
- Participation in other investigational trials within 6 months
- Moderate or severe chronic respiratory disease
- Rheumatologic disorders
- Chronic liver or kidney disease, or dialysis
- Severe heart failure or life-threatening arrhythmias
- Bleeding disorders or unable to stop anticoagulation therapy
- Unstable medical conditions such as uncontrolled hypertension or worsening asthma
- Recent use of immunosuppressive or immunomodulating agents
- Pregnant, nursing, or not using effective contraception if female
- Body mass index over 42 kg/m2
- Active infection requiring antibiotics within 12 weeks
- Active listing or history of organ transplant or rejection
- History of drug or alcohol abuse within the past 24 months
- Untreated HIV infection (treated HIV with negative viral load allowed)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single administration
Participants receive a single intra-facet injection of Alocyte at low, medium, or high dose depending on their assigned group. The treatment targets facetogenic back pain by delivering cellular therapy to affected facet joints.
1 treatment visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety and efficacy of the Alocyte treatment. Assessments include blood tests and questionnaires over the course of one year.
Visits at 1 month, 3 months, 6 months, and 12 months post-treatment
Trial Site Locations
Total: 1 location
1
The Center for Regenerative Medicine
North Miami, Florida, United States, 33161
Actively Recruiting
Research Team
I
Ileana Simon, RN
A
Alimorad Farshchian, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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