Dose Escalation Pilot Study to Evaluate the Safety of Alocyte for the Treatment of Facetogenic Ba… (NCT05909709) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of Alocyte treatment adverse events
Timeframe: through study completion, an average of 13 months
2
Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests
Timeframe: at 1 month
3
Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests
Timeframe: at 3 months
4
Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests
Timeframe: at 6 months months
5
Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel ab tests
Timeframe: at 1 month
6
Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel lab tests
Timeframe: at 3 month
7
Incidence of treatment emergent adverse events as assessed by safety complete metabolic panel lab tests