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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different platelet-based treatments to help people with degenerative disc disease, a condition causing chronic back or leg pain due to spine wear and tear. Participants will receive either platelet-rich plasma (PRP), platelet lysate (PL), platelet-poor plasma (PPP) treatments, or a sham procedure for comparison. The trial seeks individuals who have experienced back pain for over six months and have not found relief from treatments like physical therapy or injections. The goal is to determine if these platelet treatments can offer relief where other methods have failed. As an unphased trial, it provides a unique opportunity to explore innovative treatments that might succeed when others have not.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments using platelet-rich plasma (PRP), which include components like platelet lysate (PL) and platelet poor plasma (PPP), may help relieve spinal pain. Studies have found that PRP injections can significantly reduce pain and increase satisfaction for individuals with spine problems.

Evidence suggests these treatments are generally safe. Long-term studies of PRP injections have indicated they are well-tolerated, with few serious side effects reported. However, some caution is advised, and researchers continue to study the best ways to use these treatments.

Overall, the available data suggests that platelet-based therapies can be a safe option for those considering them for degenerative disc disease. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional treatments for degenerative disc disease, which often include pain medications, physical therapy, or even surgery, platelet therapies like platelet-rich plasma (PRP), platelet lysate (PL), and platelet poor plasma (PPP) offer a regenerative approach. These treatments are unique because they use components derived from the patient's own blood to promote healing and tissue regeneration in the spine. By concentrating growth factors and proteins that aid in repair, these platelet therapies have the potential to not just manage symptoms, but also address the underlying cause of the disc degeneration. Researchers are excited because this approach could lead to improved healing times and reduced reliance on more invasive procedures.

What evidence suggests that this trial's platelet-based treatments could be effective for degenerative disc disease?

Research shows that platelet-rich plasma (PRP) therapy could help treat spinal pain, such as degenerative disc disease. Some studies suggest PRP can reduce pain and improve movement in people with low back pain. In this trial, participants in the platelet treatment arm will receive PRP, platelet lysate (PL), and platelet poor plasma (PPP). Early tests have found platelet lysate safe and promising, indicating it might help with back pain related to disc problems. However, less information exists on platelet poor plasma, so its effectiveness remains uncertain. Overall, these treatments aim to use components of the blood to repair the spine and relieve pain. ^{6 7 8 9 10}

Who Is on the Research Team?

Christopher Centeno, MD

Principal Investigator

Centeno-Schultz Clinic

Are You a Good Fit for This Trial?

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 am currently on blood thinners or drugs that suppress my immune system.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7704139/

Effect of Platelet-Rich Plasma on Intervertebral Disc ... Several in vitro experiments demonstrated that platelet-rich plasma (PRP) could stimulate cell proliferation and extracellular matrix regeneration.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772594422000024

Effectiveness of intradiscal platelet rich plasma for ... Participants who received intradiscal PRP showed no significant improvement in pain or functionality compared to the control group at 1 year follow up.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12561664/

Long-Term Effectiveness of Intradiscal Culture-Expanded ... Results: Thirteen patients met the inclusion criteria. Significant reductions in NRS and FRI scores were observed at 6 months, 3 years, and 6 years (p < 0.01).

4. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1622974/full

Efficacy of platelet-rich plasma injection with percutaneous ... Our findings suggested that intraoperative PRP injection following PELD might benefit annulus fibrosus repair, delay intervertebral disc ...

5. withpower.com withpower.com/trial/phase-spinal-diseases-2-2022-6c6c3

Platelet Therapy for Degenerative Disc Disease A single intradiscal injection of platelet-rich plasma (PRP) significantly improved pain and lumbar function in 31 patients with discogenic low back pain (DLBP) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10853612/

Platelet-Rich Plasma for Degenerative Spine Disease PRP is an emerging and promising biodrug for the treatment of patients with spinal pain. PRP has demonstrated some promising qualities.

7. painphysicianjournal.com painphysicianjournal.com/current/pdf?article=NzM5MQ%3D%3D&journal=141

Safety and Efficacy of Platelet Rich Plasma for Treatment of ... This study posits necessary caution for researchers who wish to administer. PRP for therapeutic benefit and may ultimately point to necessary redirection of ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1934148215009715

Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections Participants who received intradiskal PRP showed significant improvements in FRI, NRS Best Pain, and NASS patient satisfaction scores over 8 weeks compared ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10525951/

Systematic Review of Platelet-Rich Plasma for Low Back Pain Epidural PRP injections have demonstrated long-term safety and effectiveness, with platelet lysate injections leading to pain reduction and functional ...

10. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-024-05153-5

Evaluating the impact of platelet-rich plasma injection in ... This study investigates the clinical efficacy and safety of percutaneous endoscopic nucleotomy combined with platelet-rich plasma (PRP) injection in treating ...