A Trial of Platelet Injections for Treatment of Painful Degenerative Disc Disease

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To evaluate and compare two platelet-based treatments of the functional spinal unit spaced 4 weeks apart to sham procedures for the treatment of degenerative disc disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 65
Healthy Volunteers: f
View:

• Voluntary signature of the IRB approved Informed Consent,

• Skeletally mature Male or Female ages 25 to 65

• Maximum of 3 levels degenerative disc disease without significant spondylolisthesis in the area c/w the pain (grade 1 with less than or equal to 10% vertebral body)

• Chronic back and/or leg pain having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 6 months

• MRI and physical examination consistent with painful Degenerative Disc Disease

• Failure of epidural steroid injection, facet injection, medial branch block, radiofrequency ablation or physical therapy

• Instability as seen on MRI, flexion-extension x-ray, or physical deformity as seen on MRI c/w degenerative instability (facet hypertrophy, loss of disc height, spondylolisthesis, laterolisthesis, osteophytes)

• A lumbar surgery candidate (will need to specify which surgery, ie. fusion, decompression, etc)

• Is independent, ambulatory, and can comply with all post-operative evaluations and visits

Locations
United States
Colorado
Centeno-Schultz Clinic
RECRUITING
Broomfield
Centeno-Schultz Clinic
RECRUITING
Lone Tree
Contact Information
Primary
Ehren Dodson, PhD
edodson@regenexx.com
7202877199
Backup
Neven Steinmetz, PhD
nsteinmetz@regenexx.com
Time Frame
Start Date: 2022-05-06
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 42
Treatments
Experimental: Platelet treatment
A series of two treatments spaced 4 weeks apart that include platelet-rich plasma (PRP). platelet lysate (PL), and platelet poor plasma (PPP).
Sham_comparator: Sham procedure
A series of two sham procedures spaced 4 weeks apart.
Related Therapeutic Areas
Sponsors
Leads: Regenexx, LLC

This content was sourced from clinicaltrials.gov