RecruitingPhase 1

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

United States15 participantsStarted 2024-04-29

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.

Exclusion criteria

✕. 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

What they're measuring

Safety of Alocyte treatment adverse events

Timeframe: through study completion, an average of 13 months

Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests

Timeframe: at 1 month

Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests

Timeframe: at 3 months

Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests

Timeframe: at 6 months months

Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel ab tests

Timeframe: at 1 month

Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel lab tests

Timeframe: at 3 month

Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel lab tests

Timeframe: at 6 month

Trial details

NCT IDNCT05909709

SponsorAlimorad Farshchian

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-01

Contact for this trial

Ileana Simon, RN

3058914686 ileana@genorthix.com

View on ClinicalTrials.gov More Facet Joints; Degeneration trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.

Exclusion criteria

✕. 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

What they're measuring

Safety of Alocyte treatment adverse events

Timeframe: through study completion, an average of 13 months

Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests

Timeframe: at 1 month

Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests

Timeframe: at 3 months

Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests

Timeframe: at 6 months months

Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel ab tests

Timeframe: at 1 month

Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel lab tests

Timeframe: at 3 month

Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel lab tests

Timeframe: at 6 month