Dose Escalation Pilot Study to Evaluate the Safety of Alocyte for the Treatment of Facetogenic Back Pain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlimorad Farshchian
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Alocyte low dose
- Alocyte medium dose
- Alocyte high dose
Treatment groups
15 Participants
are divided into 3 treatment groupsSponsors and collaborators
Alimorad Farshchian
Lead sponsor
The Center For Regenerative Medicine Laboratories
Sponsor institution
Source ClinicalTrials.gov