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Platelet-based Treatment

Platelet Therapy for Degenerative Disc Disease

N/A

Recruiting

Led By Christopher Centeno, MD

Research Sponsored by Regenexx, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Voluntary signature of the IRB approved Informed Consent

Skeletally mature Male or Female ages 25 to 65

Timeline

Screening 5 days

Treatment Varies

Follow Up 12 months

Awards & highlights

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.

Who is the study for?

This trial is for adults aged 25 to 65 with painful Degenerative Disc Disease confirmed by MRI and physical exam, who have not improved after specific back pain treatments and are potential candidates for lumbar surgery. It excludes smokers, those with untreated psychological conditions contributing to chronic pain, inflammatory diseases like rheumatoid arthritis, recent steroid injections, anticoagulant or immunosuppressive medication users, opioid users or drug abuse history within six months.Check my eligibility

What is being tested?

The study tests two platelet-based treatments: Platelet-rich plasma (PRP) and Platelet lysate (PL), against a sham procedure (a fake treatment that seems real) in patients with degenerative disc disease. Treatments are given four weeks apart to see which is more effective at relieving back pain.See study design

What are the potential side effects?

While the trial information does not specify side effects, common ones from similar procedures may include temporary increase in back pain, infection risk at injection site, nerve damage risks associated with spine procedures and possible allergic reactions to the substances used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 25 and 65 years old.

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I have back pain due to disc disease without major spine alignment issues.

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I have chronic back or leg pain that hasn't improved with standard treatments for over 6 months.

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My MRI and physical exam show I have painful degenerative disc disease.

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I am a candidate for lumbar spine surgery.

Timeline

Screening ~ 5 days1 visit

Treatment ~ Varies

Follow Up ~ 12 months2 visits

Screening ~ 5 days

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 5 days for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Modified Single Assessment Numerical Evaluation (SANE) scores

Secondary outcome measures

Functional Rating Index (FRI)

Incidence rate of adverse events

Incidence rate of surgical/other treatment interventions

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Platelet treatmentExperimental Treatment1 Intervention

A series of two treatments spaced 4 weeks apart that include platelet-rich plasma (PRP). platelet lysate (PL), and platelet poor plasma (PPP).

Group II: Sham procedurePlacebo Group1 Intervention

A series of two sham procedures spaced 4 weeks apart.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regenexx, LLCLead Sponsor

14 Previous Clinical Trials

50,803 Total Patients Enrolled

Christopher Centeno, MDPrincipal InvestigatorCenteno-Schultz Clinic

12 Previous Clinical Trials

50,355 Total Patients Enrolled

Media Library

Platelet lysate (PL) (Platelet-based Treatment) Clinical Trial Eligibility Overview. Trial Name: NCT05287867 — N/A

Degenerative Disc Disease Research Study Groups: Platelet treatment, Sham procedure

Degenerative Disc Disease Clinical Trial 2023: Platelet lysate (PL) Highlights & Side Effects. Trial Name: NCT05287867 — N/A

Platelet lysate (PL) (Platelet-based Treatment) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05287867 — N/A

Degenerative Disc Disease Patient Testimony for trial: Trial Name: NCT05287867 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my profile a fit for participation in this investigation?

"This research project is seeking forty-two individuals aged 25 to 65 who are presently experiencing intervertebral disc degeneration. Eligible patients must possess a skeletal maturity and have suffered from chronic back or leg anguish that has not responded to traditional treatments (e.g., physician initiated physical therapy, NSAIDs) for at least six months; they should also demonstrate instability on MRI scans or flexion-extension x-rays as well as present evidence of vertebra deformity via imaging consistent with painful Degenerative disc disease. Furthermore, any potential participant must be able to independently walk and consent to postoperative evaluations/visits in addition"

Answered by AI

Is this experiment currently open to participants?

"According to the details on clinicaltrials.gov, this trial is still in need of participants and was posted on May 6th 2022 with a last update occurring July 6th 2022."

Answered by AI

Is this study incorporating elderly individuals into its participant population?

"As specified in the inclusion criteria, individuals aged 25 to 65 are eligible for this trial. For those below 18 and above 65 years of age, there is a separate set of studies catered towards them - 4 studies available to the former group while 82 trials open up opportunities for latter demographic."

Answered by AI

How many participants are currently engaged in this clinical investigation?

"Indeed, the listing on clinicaltrials.gov substantiates that this research project is currently accepting enrolment applications. The trial was first advertised on May 6th 2022 and has been recently revised as of July 6th 2022. For now, it requires 42 participants from 2 sites for participation."

Answered by AI