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Stem Cell Therapy
Bone Marrow Concentrate for Discogenic Pain
N/A
Waitlist Available
Led By David S Levi, MD
Research Sponsored by APM Spine and Sports Physicians
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 months
Awards & highlights
Study Summary
This trial is testing whether injecting bone marrow concentrate into the discs of people with discogenic low back pain can help relieve their pain. The study is double-blind, meaning that neither the participants nor the researchers will know who is receiving the treatment until after the study is over.
Eligible Conditions
- Discogenic Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional improvement vs Placebo group 50%
Secondary outcome measures
Functional improvement treatment vs placebo 30%
Functional improvement treatment vs placebo 50%
Pain
+1 moreOther outcome measures
Adjunct therapy
Medication usage
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bone Marrow ConcentrateExperimental Treatment1 Intervention
Patients in this group will receive injection of autologous bone marrow concentrate into the suspected painful intervertebral discs.
Group II: Placebo GroupPlacebo Group1 Intervention
Patients in this group will receive an injection of normal saline dorsal to the transverse process. The bone marrow aspiration will be simulated for these patients.
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Who is running the clinical trial?
APM Spine and Sports PhysiciansLead Sponsor
David S Levi, MDPrincipal InvestigatorJordan Young Institute
Scott I Horn, DOStudy ChairJordan Young Institute
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