Amniotic Fluid Allograft for Spinal Stenosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Stenosis+2 More
Amniotic Fluid Allograft - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new treatment, hAF, for lumbosacral radicular pain due to spinal stenosis, to see if it is more effective than the current treatment, dexamethasone injection.

Eligible Conditions
  • Spinal Stenosis
  • Lumbar Region

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 2 years

2 years
The number of adverse events associated with the drug injection.
6 weeks
The percentage of participants reporting >30% improvement in SSSQ score at 6 weeks.
The percentage of participants reporting >50% improvement in NRS pain score at 6 weeks; back and leg pain separately.

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Transforaminal epidural dexamethasone injection
1 of 2
Transforaminal epidural Amniotic Fluid injection
1 of 2
Active Control
Experimental Treatment

112 Total Participants · 2 Treatment Groups

Primary Treatment: Amniotic Fluid Allograft · No Placebo Group · Phase 1 & 2

Transforaminal epidural Amniotic Fluid injection
Drug
Experimental Group · 1 Intervention: Amniotic Fluid Allograft · Intervention Types: Drug
Transforaminal epidural dexamethasone injection
Drug
ActiveComparator Group · 1 Intervention: Dexamethasone sodium phosphate · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Cell Therapy & Regenerative MedicineUNKNOWN
University of UtahLead Sponsor
990 Previous Clinical Trials
1,768,836 Total Patients Enrolled
SKAGGs FoundationUNKNOWN
Zachary L McCormick, MDPrincipal InvestigatorUniversity of Utah
2 Previous Clinical Trials
136 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of lumbar foraminal or subarticular zone stenosis, or mild-moderate central canal spinal stenosis identified by MRI or CT scan according to radiologic criteria.
You are eligible for the study if you are ≥ 18 years old.
You have leg pain with advancing imaging.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: October 10th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.