Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05909709

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

Led by Alimorad Farshchian · Updated on 2026-01-13

15

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must be 18 years of age or older at time of consent
  • Male or female participants
  • Able and willing to sign informed consent
  • Diagnosed with facetogenic back pain based on clinical evaluation
  • Have up to 5 affected facet joints
  • Chronic facetogenic pain lasting 6 months or more despite conservative treatment
  • Able to return for multiple follow-up visits
  • Women of child-bearing potential must agree to use FDA-recommended birth control for 6 months post treatment
  • Male participants must agree to use contraception and not donate sperm during the study
Not Eligible

You will not qualify if you...

  • Previous surgical intervention for back pain
  • Stem cell injections within the last year
  • Use of anticoagulants or NSAIDs within 5 days before injection
  • MRI showing severe lumbar stenosis
  • Leg pain worse than back pain
  • Pain worsens with bending forward
  • Lumbar vertebrae fractures
  • Unable to complete required assessments
  • Significant abnormal lab or clinical findings
  • Use of certain medications such as chronic narcotics, corticosteroids, anticoagulants, or investigational drugs recently
  • Serious co-morbid health conditions
  • Inflammatory arthritis or traumatic joint injuries
  • History of cancer 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 disease or jaundice
  • Severe kidney disease or dialysis
  • Severe heart failure or dangerous arrhythmias
  • Bleeding disorders or anticoagulation that cannot be stopped
  • Unstable medical conditions
  • Use of immunosuppressive or immunomodulating drugs within 21 days prior to treatment
  • Pregnant, nursing, or not using effective contraception if of childbearing potential
  • BMI over 42 kg/m2
  • Active infection needing antibiotics within 12 weeks
  • Listed or expected listing for organ transplant
  • Solid organ transplant recipients or history of organ rejection
  • History of drug or alcohol abuse within 24 months
  • Untreated HIV infection (treated and viral load negative may be eligible)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Center for Regenerative Medicine

North Miami, Florida, United States, 33161

Actively Recruiting

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Research Team

I

Ileana Simon, RN

CONTACT

A

Alimorad Farshchian, MD

CONTACT

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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