Platelet Therapy for Degenerative Disc Disease

Recruiting at 1 trial location

Overseen By Neven Steinmetz, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Academic

Sponsor: Regenexx, LLC

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

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

42 Participants Needed

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.

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 Poor Plasma (PPP)
• Platelet-rich plasma (PRP)
• Sham 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.

Platelet lysate (PL) is already approved in United States for the following indications:

Approved in United States as Platelet Lysate for:

• Degenerative disc disease
• Bulging discs
• Herniated discs

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 retrospective study of 65 patients with cervical and lumbar spine pain, treatment with plasma rich in growth factors (PRGF) showed statistically significant improvements in pain and disability scores, indicating its effectiveness as a minimally invasive treatment option.

Out of 252 cases analyzed, 62% demonstrated a statistically significant improvement post-treatment, suggesting that PRGF infiltrations can be a beneficial biological strategy for managing chronic spine pain.

NCBI (Pubmed)

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. Kirchner, F., Milani, I., Martinez, A., et al.[2021]

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]

In a study of 69 patients with symptomatic degenerative meniscal lesions (DMLs) but no knee osteoarthritis, autologous PRP injections led to significant improvements in knee function and symptoms over 12 months, with no patients requiring surgery during the follow-up.

The majority of patients reported satisfaction with the treatment, and no adverse reactions or complications were observed, suggesting that PRP injections are a safe option for managing symptoms in this patient population.

NCBI (Pubmed)

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. Alessio-Mazzola, M., Felli, L., Trentini, R., et al.[2022]

Autologous plasma rich in platelets (PRP) has shown to improve gingival recession in chronic periodontitis, with a significant effect size (SMD of 0.54) based on data from four randomized controlled trials.

The efficacy of PRP in promoting complete healing of chronic skin ulcers remains inconclusive, and while adverse effects were reported, there were no significant differences between treatment groups, indicating a need for further research on its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. Martínez-Zapata, MJ., Martí-Carvajal, A., Solà, I., et al.[2018]

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]

A 41-year-old woman developed serum sickness disease (SSD) after her third platelet rich plasma (PRP) treatment for alopecia areata, highlighting a rare but serious adverse reaction to this generally safe procedure.

The case suggests that individuals with active autoimmune diseases, like alopecia areata, may face increased risks from PRP treatments, indicating that such conditions should be considered as significant contraindications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum sickness disease in a patient with alopecia areata and Meniere' disease after PRP procedure. Owczarczyk-Saczonek, A., Wygonowska, E., Budkiewicz, M., et al.[2019]

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]

In a study involving 60 patients with knee cartilage lesions, pure platelet-rich plasma (P-PRP) injections showed significantly better short-term pain relief and functional improvement compared to leukocyte platelet-rich plasma (L-PRP) at 6 weeks post-treatment.

While both P-PRP and L-PRP demonstrated similar long-term efficacy after 12 months, the P-PRP group experienced fewer adverse events, suggesting it may be a safer option for initial treatment.

NCBI (Pubmed)

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. Zhou, Y., Li, H., Cao, S., et al.[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]

Injectable regenerative therapies, such as mesenchymal stem cells (MSC) and platelet-rich plasma (PRP), have shown significant clinical improvement in patients with degenerative disc disease, based on a systematic review of 17 studies involving 380 patients.

No major complications or adverse effects were reported from these treatments, indicating a good safety profile, although none of the studies demonstrated improvements in disc height on imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are injectable regenerative therapies effective in the treatment of degenerative disc disease? A systematic review. DI Martino, A., Barile, F., Fiore, M., et al.[2022]

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]