Microfracture vs ADSC for Knee Cartilage Repair

Recruiting at 2 trial locations

Overseen By Kaitlyn Whitney

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Previous chondral procedures, Osteoarthritis, BMI >30, others

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

Compensation: Varies

Number of Visits: 6

Duration: Immediate post-operative period

17 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for treating cartilage damage in the knee. The first is the standard microfracture technique, which relies on the body's natural healing process to repair cartilage. The second method uses adipose-derived stem cells (ADSCs) on a collagen scaffold to potentially enhance cartilage regeneration. Suitable candidates have knee cartilage damage on the thigh bone and do not have severe arthritis or a high body mass index (BMI). As an unphased trial, this study provides a unique opportunity to explore innovative treatments for cartilage damage.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

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

Research has shown that stem cells from fat tissue, known as adipose-derived stem cells (ADSCs), can repair cartilage. Studies suggest that ADSCs are generally safe for patients. Recent trials using ADSCs for cartilage repair have reported few serious side effects.

With ADSCs used in various studies, evidence increasingly supports their safety for humans. Most side effects, if they occur, are mild, such as temporary swelling or discomfort at the application site. This suggests that ADSCs could be a safe option for those considering trials for knee cartilage repair.

Microfracture, a common procedure for knee cartilage problems, has a well-known safety record. It is generally safe for most patients, though it can sometimes cause temporary pain or swelling.

In summary, both ADSC treatments and microfracture are safe for treating knee cartilage issues. ADSCs offer a newer approach that appears well-tolerated based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the ADSC application for knee cartilage repair because it uses adipose-derived stem cells, which have the potential to regenerate damaged cartilage. Unlike traditional treatments like microfracture, which rely on creating small fractures in the bone to stimulate healing, ADSC application directly targets the repair of cartilage at the cellular level, potentially leading to more effective and long-lasting results. This innovative approach offers hope for improved joint function and reduced pain, which are significant advancements over current methods.

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

This trial will compare two treatments for knee cartilage repair: ADSC Application and Microfracture. Studies have shown that fat-derived stem cells (ADSCs), which participants in this trial may receive, could be promising for repairing knee cartilage. Research indicates that ADSCs, especially when combined with platelet-rich plasma, have strong abilities to grow and form cartilage. Evidence also suggests that applying ADSCs directly to damaged cartilage leads to better tissue repair than other methods, like injections. In contrast, participants in the Microfracture arm will receive a common technique that aids healing by attracting cells from nearby bone marrow. While microfracture is effective, ADSCs might offer more targeted repair, potentially leading to better outcomes for knee cartilage regeneration. ^{1 2 3 6 7}

Who Is on the Research Team?

Seth Sherman, MD

Principal Investigator

Stanford University

Jason Dragoo, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-50 with a specific knee cartilage defect less than 400mm^2 on the femoral condyle and neutral leg alignment. It's not for those over 50 or under 18, with a BMI over 30, advanced osteoarthritis, or previous knee cartilage procedures.

Inclusion Criteria

Must have overall neutral lower limb mechanical alignment (<5 degrees varus or valgus)

I have a specific knee cartilage damage smaller than 400mm^2.

Exclusion Criteria

BMI >30

I have moderate to severe arthritis.

I am under 18 or over 50 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an arthroscopic surgical procedure, either ADSC application or microfracture, followed by physical therapy

Immediate post-operative period

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcome questionnaires and MRI scans at 6, 12, and 24 months post-operatively

24 months

Visits at 6, 12, and 24 months post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• ADSC Application
• Microfracture

Trial Overview

The study compares two treatments for knee cartilage defects: microfracture (standard care) and application of adipose-derived stem cells (ADSCs) on a collagen scaffold to potentially improve regeneration at the injury site.

How Is the Trial Designed?

Group I: ADSC Application Experimental Treatment 1 Intervention

Patients undergo an arthroscopic surgical procedure, ADSC application, followed by physical therapy.

Group II: Microfracture Arm Active Control 1 Intervention

Patients undergo an arthroscopic surgical procedure, microfracture, followed by physical therapy.

ADSC Application is already approved in United States, European Union for the following indications:

Approved in United States as Adipose-Derived Stem Cell Therapy for:

• Knee osteoarthritis
• Articular cartilage defects

Approved in European Union as ADSC Therapy for:

• Orthopedic conditions
• Regenerative medicine applications

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+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

Published Research Related to This Trial

Stem cell therapy, particularly using adipose-derived stem cells, shows great promise for repairing damaged articular cartilage, which is crucial for joint health.

The authors suggest that it is only a matter of time before stem cell treatments become cost-effective and widely available for treating cartilage injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Doc, Can You Inject Stem Cells in My Knee? Wetzler, MJ.[2018]

In a study involving 30 male rabbits with induced osteochondral defects, the application of adipose tissue-derived mesenchymal stem cells (ADSCs) after microfracture showed improved surface properties and cartilage mineralization compared to spontaneous healing.

However, the overall improvements in chondral healing with ADSC treatment were not statistically significant when compared to microfracture alone, suggesting that while ADSCs may have a positive effect, their impact may not be substantial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can chondral healing be improved following microfracture? The effect of adipocyte tissue derived stem cell therapy. Ceylan, HH., Bilsel, K., Buyukpinarbasili, N., et al.[2019]

In a study involving 9 rabbits with cartilage defects, the combination of adipose-derived stem cells (ADSCs) and platelet-rich plasma (PRP) resulted in significantly better cartilage repair compared to the microfracture technique after 12 weeks.

The enhanced repair quality was assessed using the International Cartilage Repair Society scoring system, indicating that the ADSC and PRP treatment is a promising approach for improving cartilage defect healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preliminary Study Comparing Microfracture and Local Adherent Transplantation of Autologous Adipose-Derived Stem Cells Followed by Intraarticular Injection of Platelet-Rich Plasma for the Treatment of Chondral Defects in Rabbits. Spakova, T., Amrichova, J., Plsikova, J., et al.[2019]

In a study using rabbits, adipose-derived stem cells (ADSCs) combined with a fibrin glue scaffold successfully repaired full-thickness cartilage defects, with 100% of treated defects healing with hyaline-like cartilage compared to only 8% in the control group.

The treated defects showed complete healing to the underlying bone and a high-quality cartilage structure, indicated by a favorable collagen type II:I protein ratio, suggesting that ADSCs are a promising option for cartilage tissue engineering.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing full-thickness cartilage defects using adipose-derived stem cells. Dragoo, JL., Carlson, G., McCormick, F., et al.[2022]

In a study involving 80 patients with knee cartilage defects, the combination of adipose-derived stem cells (ADSCs) with microfracture (MFX) showed significantly better radiologic outcomes and improvements in pain and symptoms compared to MFX alone, with 65% of patients in the ADSC group achieving complete cartilage coverage at 24 months.

While both treatment groups showed good repair tissue quality, the ADSC group had a higher mean histologic score, indicating better tissue quality, although no significant differences were found in activity, sports, or quality-of-life outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose-Derived Mesenchymal Stem Cells With Microfracture Versus Microfracture Alone: 2-Year Follow-up of a Prospective Randomized Trial. Koh, YG., Kwon, OR., Kim, YS., et al.[2022]

Microfracture is an effective single-stage procedure for treating small cartilage defects, showing improvement in knee function for 70% to 90% of patients, especially in the first year after surgery.

The technique is cost-effective and has low patient morbidity, making it a valuable first-line treatment option, although outcomes may decline after one year, particularly in patients with a high body mass index or incomplete fibrocartilage fill.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microfracture: indications, technique, and results. Williams, RJ., Harnly, HW.[2022]

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]

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]

The study evaluated the safety of intra-articular injections of adipose-derived stromal cells (ASCs) in 18 patients with severe knee osteoarthritis (OA) and found no serious adverse events, indicating that the treatment is safe.

Patients receiving low-dose ASCs reported significant improvements in pain and function after 6 months, suggesting potential efficacy, although further controlled studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Pers, YM., Rackwitz, L., Ferreira, R., et al.[2022]

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