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Cell Therapy

Alocyte for Back Pain

Phase 1

Recruiting

Led By Alimorad Farshchian, MD

Research Sponsored by Alimorad Farshchian

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Facetogenic back pain diagnosed using specific diagnostic criteria

Patient with up to 5 diseased facet joints

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial investigates the safety of Alocyte, a cord blood plasma and cell combination, and its ability to reduce low back pain.

Who is the study for?

This trial is for men and women over 18 with chronic back pain from facet joint issues, who've tried other treatments without success. They must be able to attend follow-ups and use contraception if of childbearing potential. Exclusions include severe diseases like cancer, liver or kidney disease, heart failure, bleeding disorders, recent other trials or treatments for back pain.Check my eligibility

What is being tested?

The study tests Alocyte at three different doses to see if it's safe and can reduce inflammation or relieve chronic back pain caused by facet joint degeneration. It involves injecting a combination of cord blood plasma and cells into the affected area.See study design

What are the potential side effects?

Potential side effects are not specified but may include reactions at the injection site, general discomfort or worsening pain temporarily after treatment. The trial aims to assess safety so close monitoring for any adverse effects will occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My back pain is diagnosed as facetogenic.

Select...

I have up to 5 affected facet joints.

Select...

I have had back pain for over 6 months and treatments haven't worked.

Select...

I am over 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 3 months, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 3 months, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 months, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment emergent adverse events as assessed by blood biomarker sample lab tests

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

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

+3 more

Secondary outcome measures

Efficacy of Alocyte Treatment for pain as assessed by the change in the Owestry Back Pain questionnaire

Efficacy of Alocyte Treatment for pain management as assessed by the change in Numeric Rating Scale (NRS) pain scale

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Alocyte Medium doseExperimental Treatment1 Intervention

Subjects will receive medium dose injections in three facet joints

Group II: Alocyte Low doseExperimental Treatment1 Intervention

Subjects will receive low dose injection in a single facet joint

Group III: Alocyte High doseExperimental Treatment1 Intervention

Subjects will receive high dose injections in five facet joints

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alimorad FarshchianLead Sponsor

Alimorad Farshchian, MDPrincipal InvestigatorThe Center For Regenerative Medicine Laboratories

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Alocyte Low dose been sanctioned by the FDA?

"Due to the fact that Alocyte Low dose is currently in Phase 1 trials, which entails minimal data regarding efficiency and security, we rate its safety as a grade 1."

Answered by AI

Is this research endeavor seeking out new participants at present?

"Affirmative. The clinicaltrial.gov repository indicates that this study is open for enrollment, with updates having been made last on November 16th 2023. This research requires 15 participants to be enrolled at a single site."

Answered by AI

To what extent is this medical study being populated by participants?

"Indeed, the online information from clinicaltrials.gov suggests that enrollment is currently live for this trial. Initiated on November 15th 2023 and last revised one day later, it seeks to select fifteen participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Alimorad Farshchian 2024. "Dose Escalation Pilot Study to Evaluate the Safety of Alocyte for the Treatment of Facetogenic Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05909709.

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