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

NCT05909709 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 00070133
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Facet Joints; Degeneration; Back Pain; Facet Joint Pain

Keywords

Back pain; Facet joint pain

Outcome Measures

Primary Outcomes (13)

• 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.

  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)

  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)

  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)

  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)

  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)

  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)

  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

  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

  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

  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)

  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)

  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)

  at 6 months

Secondary Outcomes (3)

• Efficacy of Alocyte treatment as assessed by the change in Quality of Life (QoL) SF-12 questionnaire

  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

  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

  baseline, 1 month, 3 months, 6 months, 12 months

Study Arms (3)

Alocyte Low dose

EXPERIMENTAL

Subjects will receive low dose injection in a single facet joint

Drug: Alocyte low dose

Alocyte Medium dose

EXPERIMENTAL

Subjects will receive medium dose injections in three facet joints

Drug: Alocyte medium dose

Alocyte High dose

EXPERIMENTAL

Subjects will receive high dose injections in five facet joints

Drug: Alocyte high dose

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 Low dose

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 Medium dose

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.

Alocyte High dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Alimorad Farshchian: lead

Study Sites (1)

The Center for Regenerative Medicine

North Miami, Florida, 33161, United States

RECRUITING

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alimorad Farshchian, MD

  The Center For Regenerative Medicine Laboratories

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ileana Simon, RN

CONTACT

3058914686; ileana@genorthix.com

Alimorad Farshchian, MD

CONTACT

3058914686; genorthix@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician Principal Investigator

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 18, 2023
• Study Start: April 29, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)