Stem Cell Transplantation + Arthroscopy for Knee Osteoarthritis

Recruiting at 2 trial locations

Overseen By Kaitlyn Whitney

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Age, Severe osteoarthritis, Prior surgery, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-surgery

29 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed osteoarthritis between the following two groups: 1. Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with standard arthroscopic treatment consisting of: partial meniscectomy, cartilage stabilization, loose body removal and selective synovectomy. 2. Standard arthroscopic treatment (above) without cell transplant.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should have tried anti-inflammatory medications as part of conservative therapy before joining the trial.

What data supports the idea that Stem Cell Transplantation + Arthroscopy for Knee Osteoarthritis is an effective treatment?

The available research shows that Stem Cell Transplantation combined with Arthroscopy is effective for treating knee osteoarthritis. One study found that patients with early knee osteoarthritis experienced significant improvements in their symptoms after receiving this treatment. Another study reported that patients with severe knee osteoarthritis had less pain and better function, along with cartilage regeneration, after undergoing the treatment. Additionally, a study showed that pain decreased by 83% and function improved by 84% after one year of treatment. These results suggest that this treatment can significantly improve symptoms and may even help preserve the knee joint in advanced cases. ^{1 2 3 4 5}

What safety data exists for stem cell and arthroscopy treatment for knee osteoarthritis?

The treatment involving adipose-derived stem cells (ADSCs) and arthroscopy for knee osteoarthritis has been shown to be safe across multiple studies. No serious adverse events were reported in trials involving ADSC therapy, either alone or combined with arthroscopic procedures. The studies consistently reported significant improvements in pain and function, with minimal complication rates. The treatment appears to be well-tolerated and effective in improving symptoms and potentially modifying disease progression. ^{1 2 3 5 6}

Is the treatment of arthroscopic debridement with stem cell transplantation promising for knee osteoarthritis?

Yes, the treatment of arthroscopic debridement with stem cell transplantation shows promise for knee osteoarthritis. Studies suggest that it can improve pain and function, and even help regenerate cartilage in the knee, making it a potential option for preserving the joint in patients with knee osteoarthritis. ^{1 5 7 8 9}

Research Team

Seth Sherman, MD

Principal Investigator

Stanford University

Jason L Dragoo, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for adults aged 35-70 with mild to moderate knee osteoarthritis who haven't had relief from physical therapy and anti-inflammatory meds. It's not for those outside the age range, with severe or little to no arthritis, prior fat pad injuries/surgeries, or recent knee surgeries.

Inclusion Criteria

Patient is scheduled to undergo one or a combination of the following procedures: Meniscal debridement or partial menisectomy, Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy, Removal of loose bodies, Chondroplasty, Synovectomy, Soft tissue releases for flexion or extension contracture, Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral femoral condyle (Kellgren-Lawrence Grade 2 or 3), < 6 months of knee pain or < 6 months of a significant exacerbation of existing knee pain, Physical examination findings consistent with the proposed surgical procedure, Failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications, with or without concomitant bracing and/or injections

I am between 35 and 70 years old.

Exclusion Criteria

I am scheduled for knee surgery that is not major and does not change my recovery plan.

I am younger than 35 or older than 70.

My X-rays show I have no, mild, or severe arthritis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either adipose-derived stem cell transplantation with standard arthroscopic treatment or standard arthroscopic treatment alone

Immediate post-surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at 1, 6, 12, and 24 months

Treatment Details

Interventions

• Arthroscopic debridement only
• Arthroscopic debridement with stem cell transplantation

Trial Overview The study compares two treatments: one group receives standard arthroscopic treatment plus stem cells from their own fat tissue; the other gets just the standard treatment without stem cells. The goal is to see which method better improves knee function.

Participant Groups

Group I: Stem Cells Experimental Treatment 1 Intervention

Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.

Group II: Placebo Active Control 1 Intervention

Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation

Arthroscopic debridement only is already approved in United States, European Union for the following indications:

Approved in United States as Arthroscopic debridement for:

• Knee osteoarthritis
• Joint pain relief
• Cartilage stabilization

Approved in European Union as Arthroscopic debridement for:

• Knee osteoarthritis
• Joint pain relief
• Cartilage stabilization

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Findings from Research

In a study of 52 patients with early knee osteoarthritis, the combination of autologous adipose-derived stem cell injections and arthroscopic debridement significantly improved knee function and reduced pain over an average follow-up of 15.3 months.

Patients with higher pre-operative pain levels (VAS score > 8) experienced greater improvements in clinical and functional outcomes, suggesting that this treatment may be particularly beneficial for those with more severe symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of autologous adipose-derived stem cells in early knee osteoarthritis: identification of a subpopulation with greater response. Schiavone Panni, A., Vasso, M., Braile, A., et al.[2020]

Intra-articular injection of autologous purified adipose tissue significantly reduced pain in knee osteoarthritis patients, with a 53% decrease after 1 month and an 83% decrease after 1 year, based on VAS scores.

The treatment also led to a 47% improvement in functional recovery after 1 month and an 84% improvement after 1 year, with no reported adverse effects, indicating both safety and efficacy over a 12-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-Articular Administration of Autologous Purified Adipose Tissue Associated with Arthroscopy Ameliorates Knee Osteoarthritis Symptoms. Caforio, M., Nobile, C.[2021]

In a study involving 30 participants with knee osteoarthritis, autologous adipose-derived mesenchymal stem cell (ADMSC) therapy was found to be safe, with no serious adverse events reported.

Both treatment groups receiving ADMSC injections showed significant improvements in pain and function after 12 months, and MRI results suggested that the therapy may help slow down disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose-derived mesenchymal stem cell therapy in the treatment of knee osteoarthritis: a randomized controlled trial. Freitag, J., Bates, D., Wickham, J., et al.[2019]

Intra-articular administration of adipose tissue-derived stem cells (ADSC) significantly improved knee function and pain scores (KOOS) at 6 months, especially in patients with moderate OA (Kellgren-Lawrence grades 2 and 3) compared to those with severe OA (grade 4).

The study found that while KOOS scores improved, changes in cartilage volume after ADSC treatment did not correlate with these clinical improvements, suggesting that the mechanism of action may not solely depend on cartilage volume changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular injection of culture-expanded adipose tissue-derived stem cells for knee osteoarthritis: Assessments with clinical symptoms and quantitative measurements of articular cartilage volume. Kuwasawa, A., Okazaki, K., Noda, K., et al.[2023]

In a study involving 27 patients with advanced knee osteoarthritis, the combination of adipose-derived mesenchymal stem cell (ADMSC) therapy and arthroscopic abrasion arthroplasty (AAA) was found to be safe, with no serious adverse events reported over a 36-month follow-up period.

Patients experienced significant improvements in pain and function, along with observable cartilage regeneration, indicating that this combined treatment could effectively preserve knee joint health in advanced osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mesenchymal stem cell therapy combined with arthroscopic abrasion arthroplasty regenerates cartilage in patients with severe knee osteoarthritis: a case series. Freitag, J., Wickham, J., Shah, K., et al.[2021]

Adipose-derived stem cell (ADSC) or stromal vascular fraction (SVF) injections are safe and show good clinical and radiological outcomes for knee osteoarthritis treatment, with a low complication rate of 16.15% for minor issues.

The study indicates that ADSCs and SVF can lead to promising improvements in knee osteoarthritis symptoms within 12-24 months, but highlights the need for more standardized follow-up and comparisons with other treatments to confirm efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous adipose stem cell therapy for knee osteoarthritis: where are we now? Biazzo, A., D'Ambrosi, R., Masia, F., et al.[2021]

In a study of 43 patients with knee osteoarthritis and mechanical symptoms, arthroscopic debridement led to significant improvements in pain and function, with median pain scores decreasing from 7 to 5 and Oxford Knee Scores increasing from 24 to 36.5 after a mean follow-up of 1.5 years.

The procedure was found to be cost-effective, generating a cost per quality-adjusted life year (QALY) of £2,088, which is well below the £30,000 threshold set by the UK National Institute for Health and Care Excellence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopy for mechanical symptoms in osteoarthritis: a cost-effective procedure. Hutt, JR., Craik, J., Phadnis, J., et al.[2022]

Arthroscopic treatment for knee osteoarthritis, which includes various procedures like debridement and meniscectomy, has been commonly performed, but its overall effectiveness remains debated in the medical community.

Proper patient selection is crucial for achieving successful outcomes with arthroscopic interventions in knee osteoarthritis, highlighting the need for careful evaluation before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic treatment for osteoarthritic knee. Shin, CS., Lee, JH.[2021]

In a study of 80 patients with knee osteoarthritis, adipose-derived stromal cell (ASC) injections showed significantly better improvements in pain and function compared to stromal vascular fraction (SVF) injections, particularly at the 12-month mark.

While both treatments improved outcomes, ASC injections were more effective in helping patients achieve clinically meaningful improvements, and there was no added benefit from booster ASC injections after the initial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Safety and Effectiveness of Adipose-Derived Stromal Cell vs Stromal Vascular Fraction Injection for Treatment of Knee Osteoarthritis: 2-Year Results of Parallel Single-Arm Trials. Yokota, N., Lyman, S., Hanai, H., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Preliminary results of autologous adipose-derived stem cells in early knee osteoarthritis: identification of a subpopulation with greater response. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Intra-Articular Administration of Autologous Purified Adipose Tissue Associated with Arthroscopy Ameliorates Knee Osteoarthritis Symptoms. [2021]

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

Adipose-derived mesenchymal stem cell therapy in the treatment of knee osteoarthritis: a randomized controlled trial. [2019]

4. Japan pubmed.ncbi.nlm.nih.gov

Intra-articular injection of culture-expanded adipose tissue-derived stem cells for knee osteoarthritis: Assessments with clinical symptoms and quantitative measurements of articular cartilage volume. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Mesenchymal stem cell therapy combined with arthroscopic abrasion arthroplasty regenerates cartilage in patients with severe knee osteoarthritis: a case series. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Autologous adipose stem cell therapy for knee osteoarthritis: where are we now? [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Arthroscopy for mechanical symptoms in osteoarthritis: a cost-effective procedure. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Arthroscopic treatment for osteoarthritic knee. [2021]

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

Clinical Safety and Effectiveness of Adipose-Derived Stromal Cell vs Stromal Vascular Fraction Injection for Treatment of Knee Osteoarthritis: 2-Year Results of Parallel Single-Arm Trials. [2022]