Platelet Therapy for Degenerative Disc Disease

Recruiting at1 trial location

Overseen by Christopher Centeno, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Regenexx, LLC

Must not be taking: Anticoagulants, Immunosuppressives, Opioids, others

Disqualifiers: Smoker, Untreated psychological conditions, Inflammatory pathology, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment that uses a part of the patient's own blood to help heal damaged spinal discs. It targets patients with back pain due to degenerative disc disease. The treatment aims to use the body's natural healing cells to reduce pain and improve function.

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulant (blood-thinning) or immunosuppressive medications. If you are using chronic opioids, you will also need to stop.

What data supports the effectiveness of the treatment Platelet-rich plasma (PRP) for Degenerative Disc Disease?

Research shows that platelet-rich plasma (PRP), which is rich in growth factors, can help improve intervertebral disc degeneration and reduce low back pain. Studies have demonstrated its potential to promote healing and tissue repair in conditions similar to degenerative disc disease. ^{1 2 3 4 5}

Is platelet therapy safe for humans?

Platelet-rich plasma (PRP) is generally considered a very safe treatment option for various injuries, with adverse reactions being extremely rare. ^{5 6 7 8 9}

How is platelet therapy different from other treatments for degenerative disc disease?

Platelet therapy, including platelet-rich plasma (PRP), is unique because it uses components from your own blood to promote healing and reduce inflammation in the discs of your spine. Unlike traditional treatments, it involves injecting concentrated growth factors directly into the affected area to help repair tissue and improve symptoms. ^{1 2 10 11 12}

Research Team

Christopher Centeno, MD

Principal Investigator

Centeno-Schultz Clinic

Eligibility Criteria

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.

Inclusion Criteria

I have degenerative disc disease in up to 3 levels without major spine misalignment.

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

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

Exclusion Criteria

Documented history of drug abuse within six months of treatment

Hypermobile or EDS

I have not had an epidural steroid injection in the last 8 weeks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pretreatment

A pretreatment visit occurs at or before the time of enrollment

1 week

1 visit (in-person)

Treatment

Participants receive a series of two platelet-based treatments spaced 4 weeks apart

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 visits (in-person) at 1, 3, 6, and 12 months

Crossover

Control group participants can crossover to the treatment group after 3-month follow-up

9 months

Treatment Details

Interventions

• Platelet lysate (PL) (Platelet-based Treatment)
• Platelet Poor Plasma (PPP) (Platelet-based Treatment)
• Platelet-rich plasma (PRP) (Platelet-based Treatment)
• Sham procedure (Procedure)

Trial Overview 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.

Participant Groups

Group I: Platelet treatment Experimental Treatment 1 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 procedure Placebo Group 1 Intervention

A series of two sham procedures spaced 4 weeks apart.

Who Is Running the Clinical Trial?

Regenexx, LLC

Lead Sponsor

Trials

15

Recruited

50,800+

Findings from Research

A single intradiscal injection of platelet-rich plasma (PRP) significantly improved pain and lumbar function in 31 patients with discogenic low back pain (DLBP) over a 48-week follow-up period, with 71% of patients classified as treatment successes.

The study reported a high follow-up rate of 94%, but noted one case of intervertebral discitis requiring surgery, indicating the need for further randomized controlled trials to fully assess the safety and efficacy of PRP injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradiscal Autologous Platelet-Rich Plasma Injection for Discogenic Low Back Pain: A Clinical Trial. Zhang, J., Liu, D., Gong, Q., et al.[2022]

In a study involving 12 rabbits with induced intervertebral disc degeneration, the injection of autologous PRP-releasate significantly restored disc height compared to controls, indicating its potential efficacy in treating disc degeneration.

Histological analysis showed a higher number of chondrocyte-like cells in discs treated with PRP-releasate, suggesting that it promotes cellular repair and regeneration in degenerated intervertebral discs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of autologous platelet-rich plasma-releasate on intervertebral disc degeneration in the rabbit anular puncture model: a preclinical study. Obata, S., Akeda, K., Imanishi, T., et al.[2022]

A systematic review of 19 studies revealed significant variability in the concentrations of platelets, leukocytes, and growth factors in platelet-rich plasma (PRP) produced by different separation systems, indicating that not all PRP is created equal.

The choice of PRP separation system should be tailored to the specific clinical application, as the ideal concentrations for effective treatment are still not well-defined, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concentrations of Blood Components in Commercial Platelet-Rich Plasma Separation Systems: A Review of the Literature. Oudelaar, BW., Peerbooms, JC., Huis In 't Veld, R., et al.[2020]

Platelet-rich plasma (PRP) therapy, which has been used for 20 years, shows potential for treating tendon, ligament, and joint diseases, although determining its efficacy has been challenging due to varying definitions and classifications.

Recent advancements include the development of PRP lysates optimized for antibiofilm and antimicrobial properties, suggesting a promising direction for enhancing the therapeutic effects of PRP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equine Platelet-Rich Plasma. McCarrel, TM.[2023]

Platelet-rich plasma (P-PRP) significantly promotes the proliferation and differentiation of nucleus pulposus-derived stem cells (NPSCs) from early degenerated intervertebral discs, with optimal effects observed at a 10% concentration.

In contrast, leukocyte-platelet-rich PRP (L-PRP) triggers inflammatory and catabolic responses in NPSCs, suggesting that P-PRP is a safer and more effective treatment option for early intervertebral disc degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is exclusion of leukocytes from platelet-rich plasma (PRP) a better choice for early intervertebral disc regeneration? Wang, SZ., Fan, WM., Jia, J., et al.[2019]

Platelet-rich plasma (PRP) therapy is a feasible and minimally invasive treatment for knee osteoarthritis, showing improvements in pain and patient satisfaction among 12 participants who completed the study.

The study reported no serious adverse events, indicating that PRP injections are safe, with only one patient experiencing mild pain and stiffness after the first injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma (PRP) therapy for knee arthritis: a feasibility study in primary care. Glynn, LG., Mustafa, A., Casey, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intradiscal Autologous Platelet-Rich Plasma Injection for Discogenic Low Back Pain: A Clinical Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Plasma Rich in Growth Factors (PRGF) in the Treatment of Cervical and Lumbar Back Pain: A Retrospective Observational Clinical Study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effect of autologous platelet-rich plasma-releasate on intervertebral disc degeneration in the rabbit anular puncture model: a preclinical study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Autologous Platelet-Rich Plasma Injections for Grade 3 Symptomatic Degenerative Meniscal Lesions: A 1-Year Follow-up Prospective Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Concentrations of Blood Components in Commercial Platelet-Rich Plasma Separation Systems: A Review of the Literature. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Serum sickness disease in a patient with alopecia areata and Meniere' disease after PRP procedure. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Equine Platelet-Rich Plasma. [2023]

9. Australia pubmed.ncbi.nlm.nih.gov

Clinical Efficacy of Intra-Articular Injection with P-PRP Versus that of L-PRP in Treating Knee Cartilage Lesion: A Randomized Controlled Trial. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Is exclusion of leukocytes from platelet-rich plasma (PRP) a better choice for early intervertebral disc regeneration? [2019]

11. England pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma (PRP) therapy for knee arthritis: a feasibility study in primary care. [2023]

12. Italy pubmed.ncbi.nlm.nih.gov

Are injectable regenerative therapies effective in the treatment of degenerative disc disease? A systematic review. [2022]