Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP) for Degenerative Disc Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Degenerative Disc DiseasePlatelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP) - Biological
Eligibility
25 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is comparing two different treatments for degenerative disc disease, both of which involve platelets. One group will receive the treatment 4 weeks apart, and the other group will receive sham procedures.

Eligible Conditions
  • Degenerative Disc Disease

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 1-month, 3-months, 6 months, 12 months

Month 12
Incidence rate of surgical/other treatment interventions
Month 12
Incidence rate of adverse events
Pain medications
Month 12
Mean modified SANE scores
3-months after 2nd treatment
Modified Single Assessment Numerical Evaluation (SANE) scores
Month 12
Functional Rating Index (FRI)
Numeric Pain Scale (NPS)
Oswestry Disability Index (ODI)

Trial Safety

Trial Design

2 Treatment Groups

Platelet treatment
1 of 2
Sham procedure
1 of 2

Experimental Treatment

Non-Treatment Group

42 Total Participants · 2 Treatment Groups

Primary Treatment: Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP) · Has Placebo Group · N/A

Platelet treatment
Biological
Experimental Group · 1 Intervention: Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP) · Intervention Types: Biological
Sham procedure
Other
ShamComparator Group · 1 Intervention: Sham procedure · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1-month, 3-months, 6 months, 12 months

Who is running the clinical trial?

Regenexx, LLCLead Sponsor
14 Previous Clinical Trials
51,356 Total Patients Enrolled
Christopher Centeno, MDPrincipal InvestigatorCenteno-Schultz Clinic
12 Previous Clinical Trials
50,908 Total Patients Enrolled

Eligibility Criteria

Age 25 - 65 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient has degenerative disc disease without significant spondylolisthesis in the area c/w the pain.
Failure of epidural steroid injection, facet injection, medial branch block, radiofrequency ablation or physical therapy.
You are independent, ambulatory, and can comply with all post-operative evaluations and visits.

Who else is applying?

What state do they live in?
Utah33.3%
Hawaii33.3%
Iowa33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Centeno-Schultz Clinic100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria66.7%
Met criteria33.3%

How responsive is this trial?

Most responsive sites:
  1. Centeno-Schultz Clinic: < 48 hours
Typically responds via
Email100.0%
Average response time
  • < 2 Days
References