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Stem Cell Therapy for Lower Back Pain (Cellkine Trial)
Cellkine Trial Summary
This trial is testing the side effects of a stem cell treatment for a painful back condition.
Cellkine Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCellkine Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Cellkine Trial Design
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Who is running the clinical trial?
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- I have severe osteoporosis with a bone fracture.I have not had an epidural steroid injection in the last 4 weeks.My back pain was confirmed to be from facet joints by a successful nerve block test.I have been diagnosed with painful joint issues in my lower back.I do not have serious heart, brain, kidney, liver, or hormone-related diseases.I am on a high dose of pain medication.I am on medication that weakens my immune system or have a condition that does so.You have a mental illness that might make it hard for you to finish the study or answer questions as per the plan.You have a history of alcohol or drug abuse, or currently use drugs or alcohol recreationally.I've had a steroid injection in my lower back within the last 3 months.I cannot have an MRI or do not want to undergo certain imaging tests.X-rays or scans show that there is a problem with the joints in the lower back.I have had a treatment that uses living organisms or substances from living organisms.I have a significant spinal deformity.I've had surgery that changed the structure of my spine near the painful area.I have had or currently have a spinal infection.I have not been in a study for facet joint problems in the last year.I currently have or recently had a broken spine.I have taken medication for rheumatic disease in the last 3 months.I have chronic low back pain that may spread to my buttock, groin, or upper thigh.I have had unexplained fever or confusion recently.You are extremely overweight, with a body mass index (BMI) higher than 40, according to the NIH guidelines.You are currently involved in a legal case related to your low back pain.I am between 40 and 70 years old.I had successful radiofrequency ablation treatment at the target area within the last 3 months.I have had cancer or symptoms from a tumor within the last 5 years.You have a significant abnormality in your blood test results.I currently have an infectious disease.The primary investigator finds that you have significant movement issues when bending and straightening your body.
- Group 1: BM-MSC injections for low back pain
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are persons aged 30 and over eligible to join this experiment?
"This particular trial is looking to recruit patients who are between 40 and 70 years old. For those seeking medical studies with younger or more elderly participants, there are 19 trials involving people under 18 and 332 for those over 65."
Are there any restrictions on who can participate in this experiment?
"This research project is recruiting 10 individuals aged 40 - 70 who experience chronic low back pain with or without radiculopathy in the buttock, groin, and proximal thigh regions."
Has the FDA authorized single bilaterally-administered injections of allogeneic bone marrow stem cells for lumbar facet joint arthropathy?
"Our team at Power gauged the safety of Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathy to be a 1 since it is in Phase 1, with minimal data affirming its efficacy and security."
What objectives does this clinical trial seek to achieve?
"This two-year assessment is primarily focused on measuring the adverse effects that could be associated with this treatment. Secondary metrics also comprise of changes in AST levels (a serological test to measure liver enzyme activity), a self-reported Narcotic Use questionnaire, and platelet count (another laboratory analysis)."
Is enrollment ongoing in this experiment?
"Confirmed, this trial is not actively enrolling patients. Initially published on April 28th 2020 and last edited May 11th 2022, there are no current recruitment efforts in place; however 412 other medical studies are currently seeking participants."
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