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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding stem cell transplants to standard knee surgery improves outcomes for people with mild to moderate knee osteoarthritis. It compares two groups: one receiving standard arthroscopic surgery (a type of keyhole surgery for joint problems) and another receiving the same surgery plus a stem cell transplant. The trial seeks participants who have experienced knee pain for less than six months and have already tried physical therapy and anti-inflammatory medications without success. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment options for knee osteoarthritis.

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.

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

Research has shown that using stem cells from fat tissue to treat knee osteoarthritis is generally safe. Studies have found that combining these stem cells with minimally invasive knee surgery, known as arthroscopic surgery, often results in less pain and improved knee function for patients. Importantly, patients tolerated the treatment well.

One study found that this combination treatment improved symptoms more effectively than other treatments, with no major side effects reported. Another study noted that patients experienced less pain and some regrowth of cartilage, indicating healing in the knee.

In summary, research suggests that using stem cells with arthroscopic surgery is safe for people with knee osteoarthritis and can help reduce pain and improve knee function. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using stem cell transplantation combined with arthroscopic debridement for knee osteoarthritis because it introduces an innovative approach that goes beyond just cleaning out damaged tissue. Unlike traditional treatments like pain medications and physical therapy, this method uses stem cells harvested from a patient's own fat to potentially regenerate damaged cartilage, offering a chance to actually repair the knee joint. This regenerative capability is what sets it apart and offers hope for a more lasting solution compared to current options that mainly focus on symptom management.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Research has shown that using stem cells from fat tissue, combined with a type of knee surgery, can improve symptoms of knee osteoarthritis. In this trial, one group of participants will receive this combination treatment of stem cell transplantation with arthroscopic debridement. Studies indicate that patients receiving this combination often experience less pain and improved knee movement. Evidence also suggests it can promote cartilage regrowth, benefiting long-term joint health. Some research points to significant improvements in mobility and pain levels over two years. These findings suggest that adding stem cells to standard knee treatments might offer additional benefits for people with osteoarthritis. Meanwhile, another group of participants will receive standard arthroscopic debridement without stem cell transplantation. ^{1 2 3 6 7}

Who Is on the Research Team?

Seth Sherman, MD

Principal Investigator

Stanford University

Jason L Dragoo, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5795060/

Adipose-Derived Stem Cell Transplant Technique for ... Treated patients showed improved mobility and function and reduced pain scores. ... At 2-year follow-up, patients had significantly improved Western Ontario and ...

2. tandfonline.com tandfonline.com/doi/full/10.2217/rme-2020-0128

Full article: Mesenchymal Stem Cell Therapy Combined ... Stem cell therapy combined with keyhole knee surgery in advanced OA leads to reduced pain, increased knee function and regrowth of cartilage.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11586737/

Adipose-derived stem cells and knee osteoarthritis Ulivi et al[37] concluded that MFAT and arthroscopic debridement improved functional outcomes and magnetic resonance imaging appearance compared to isolated ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1063458424012007

Mesenchymal stem cells for chronic knee pain secondary ... Intra-articular injection of MSCs for chronic knee pain associated with OA probably provides little to no improvement in pain or physical function.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03014401/the-effect-of-adipose-derived-stem-cells-for-knee-osteoarthritis

The Effect of Adipose-Derived Stem Cells for Knee ... The purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed ...

6. trials.arthritis.org trials.arthritis.org/trials/NCT03014401

The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis The purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed osteoarthritis between ...

7. wjgnet.com wjgnet.com/1948-0210/full/v15/i12/1063.htm

Mid-term outcomes of microfragmented adipose tissue ... We demonstrated that MFAT injection combined with arthroscopic surgery had better clinical efficacy than control group for treating KOA at a mid-term follow-up.