Stem Cell Injections for Osteoarthritis

Overseen By Maimuna F Ahmed, MBBS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Grigory Karmy

Must not be taking: Immunosuppressives, Chemotherapeutics

Disqualifiers: Pregnancy, Malignancy, Autoimmune diseases, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of stem cell injections in easing pain and improving function for individuals with knee or hip osteoarthritis. It compares two types of injections: one derived from fat tissue (lipoaspirate concentrate) and another from bone marrow (bone marrow aspirate). Individuals who have experienced knee or hip osteoarthritis for at least 12 weeks without relief from other treatments may qualify. Participants receive a single injection into the affected joint to determine which method provides better pain relief and mobility. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from innovative pain relief methods.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have used certain injections in the joint within a few months before the trial. Also, you cannot use systemic immunosuppressives, immunomodulators, or chemotherapeutic agents within 3 months before the trial.

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

Research shows that both Bone Marrow Aspirate and Lipoaspirate Concentrate treatments are promising and safe for people with osteoarthritis.

For Bone Marrow Aspirate, studies have found it to be safe. One review showed that these injections can reduce pain and improve joint function without major safety concerns. In another study, patients reported significant improvements in their knee condition over several years with this treatment.

Similarly, Lipoaspirate Concentrate, which uses stem cells from fat, is also considered safe. A review found that it improved outcomes for older patients without notable safety issues. Another study highlighted that this treatment provides long-term pain relief and better joint function.

Past research has shown that both treatments are well-tolerated, with no serious side effects reported. This suggests they could be safe options for people considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for osteoarthritis, which often include pain relievers and anti-inflammatory medications, these investigational stem cell injections offer a regenerative approach. Lipoaspirate concentrate and bone marrow aspirate are both rich in stem cells, which have the potential to repair damaged joint tissues and reduce inflammation naturally. Researchers are excited because these treatments might not only alleviate symptoms but also slow the progression of osteoarthritis by targeting the root cause rather than just managing pain.

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

Research has shown that bone marrow aspirate injections can help treat knee osteoarthritis (OA). Studies found that patients with moderate to severe knee OA experienced less pain and improved movement after treatment. For hip OA, some patients reported a pain reduction of 50% or more within 6 to 12 months. In this trial, participants in the knee arm will receive either a lipoaspirate concentrate or bone marrow aspirate injection, while those in the hip arm will also be randomized to receive one of these treatments.

Similarly, lipoaspirate concentrate, rich in stem cells, might help lower inflammation and protect joint cartilage. A review found that treatments using cells from fat tissue improved joint function over time. Both treatments show promise for reducing pain and improving movement in OA patients. ^{2 3 5 6 7}

Who Is on the Research Team?

Grigory Karmy, MD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for Canadian residents aged 18-95 with moderate to severe knee or hip osteoarthritis pain, who've tried treatments like physiotherapy, injections, and oral painkillers. They must be able to follow the study plan and have a BMI ≤ 50 kg/m2. People with autoimmune diseases, allergies to certain anesthetics or anticoagulants, or metal implants in the affected joint cannot join.

Inclusion Criteria

Written informed consent to participate in the study

I am taking pain medication that can be bought without a prescription.

Residents of Canada

Exclusion Criteria

History of autoimmune diseases including lupus and rheumatoid arthritis

Know hypersensitivity to lidocaine, epinephrine or heparin

I have metal rods, screws, or a joint replacement in the joint needing injection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intra-articular injection of either Lipoaspirate Concentrate or Bone Marrow Aspirate to the knee or hip

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain reduction, functional improvement, stiffness, global impression of change, and safety after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bone Marrow Aspirate
• Lipoaspirate Concentrate

Trial Overview The study tests if one injection of Lipoaspirate Concentrate (fat-derived cells) is more effective than Bone Marrow Aspirate (bone marrow-derived cells) at reducing pain and improving function in osteoarthritic knees and hips.

How Is the Trial Designed?

Group I: Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate Active Control 1 Intervention

The subjects will be randomized to one of the treatment groups separately for the knee and hip arms of the study. Groups C will receive a single intra-articular injection with lipoaspirate concentrate to the hip and Group D will receive a single intra-articular injection with bone marrow aspirate.

Group II: Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate Active Control 1 Intervention

The Subjects will be randomized to one of the treatment groups separately for the knee and hip arms of the study. Group A will receive a single intra-articular injection with lipoaspirate concentrate to the knee and Group B will receive a single intra-articular injection with bone marrow aspirate concentrate.

Bone Marrow Aspirate is already approved in United States for the following indications:

Approved in United States as Bone Marrow Aspirate Concentrate for:

• Knee osteoarthritis
• Hip osteoarthritis

Who Is Running the Clinical Trial?

Grigory Karmy

Lead Sponsor

Trials

1

Recruited

400+

Published Research Related to This Trial

Intra-articular injections of bone marrow aspirate concentrate (BMC) for early knee and hip osteoarthritis showed significant improvement in patient-reported outcomes, with scores decreasing from 40.8% to 20.6% (P < .001) over an average follow-up of 13.2 months.

The treatment was deemed safe, with a satisfaction rate of 63.2%, and 64% of patients achieved the minimal clinically important difference, although two patients required total hip arthroplasty within 8 months post-injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Clinical Outcomes of Intra-Articular Injections of Bone Marrow Aspirate Concentrate for the Treatment of Early Osteoarthritis of the Hip and Knee: A Cohort Study. Rodriguez-Fontan, F., Piuzzi, NS., Kraeutler, MJ., et al.[2022]

Both bone marrow aspirate concentrate (BMAC) and stromal vascular fraction (SVF) injections led to significant improvements in knee pain and function in patients with osteoarthritis, based on a meta-analysis of 10 studies involving 472 patients.

SVF injections were found to be more effective in reducing knee pain compared to BMAC, although both treatments showed similar improvements in overall function, highlighting the need for careful consideration of injection methods and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Efficacy of Bone Marrow Aspirate Concentrate Versus Stromal Vascular Fraction Injection in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. Bolia, IK., Bougioukli, S., Hill, WJ., et al.[2022]

A study involving 86 patients with knee osteoarthritis is investigating whether combining subchondral and intra-articular injections of bone marrow aspirate concentrate (BMAC) leads to greater improvements in knee pain and function compared to intra-articular injections alone.

The primary outcome will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index, with additional assessments at 12 months, providing a comprehensive evaluation of the treatment's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective double-blind randomised controlled trial protocol comparing bone marrow aspirate concentrate intra-articular injection combined with subchondral injection versus intra-articular injection alone for the treatment of symptomatic knee osteoarthritis. Silva, S., Andriolo, L., Boffa, A., et al.[2022]

Intra-articular injection of autologous bone marrow aspirates concentrate (BMAC) combined with adipose tissue significantly reduced knee pain and improved function in 41 patients with degenerative knee arthritis over a 12-month period, as measured by various scoring systems.

The treatment was particularly more effective in patients with early to moderate stages of osteoarthritis (Kellgren-Lawrence grades I-III), while those with advanced arthritis (grade IV) showed less improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcome of autologous bone marrow aspirates concentrate (BMAC) injection in degenerative arthritis of the knee. Kim, JD., Lee, GW., Jung, GH., et al.[2022]

Bone marrow aspirate concentrate (BMAC) is safe for treating knee pain due to osteoarthritis, with no serious adverse events reported in a study of 25 patients.

Both BMAC and saline injections resulted in significant pain relief over time, but there was no significant difference in pain reduction between the two treatments, suggesting that further research is needed to understand the true efficacy of BMAC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Single-Blind, Placebo-Controlled Trial of Bone Marrow Aspirate Concentrate for Knee Osteoarthritis. Shapiro, SA., Kazmerchak, SE., Heckman, MG., et al.[2022]

Intra-articular injections of low-volume bone marrow aspirate harvested using the Marrow Cellution™ device significantly reduced pain in knee osteoarthritis patients, with VAS scores improving from 7.29 to 3.76 over six months (p < 0.0001).

A substantial 71% of patients showed improvements in VAS scores that surpassed the minimal clinically important difference, indicating that this treatment is not only effective but also leads to meaningful pain relief and improved function in daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-Term Efficacy of Using a Novel Low-Volume Bone Marrow Aspiration Technique to Treat Knee Osteoarthritis: A Retrospective Cohort Study. Kuebler, D., Schnee, A., Moore, L., et al.[2022]

Bone marrow aspirate concentrate (BMAC) injections show promise for treating osteoarthritis (OA), with 22 studies involving 4626 patients indicating overall safety and low adverse events.

Most studies reported improvements in pain and function, but significant variability in study quality and methodology suggests that more rigorous, large-scale trials are needed to confirm BMAC's effectiveness in OA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone marrow concentrate injections for the treatment of osteoarthritis: evidence from preclinical findings to the clinical application. Cavallo, C., Boffa, A., Andriolo, L., et al.[2022]

Bone marrow aspirate (BMA) contains a higher concentration of mesenchymal stem cells (MSCs) and more colony-forming units (CFUs) compared to bone marrow aspirate concentrate (BMAC), indicating that BMA may be more effective for cell-based therapies.

BMAC failed to concentrate MSCs in 6 out of 8 samples tested, highlighting significant variability in MSC quantity and potency between BMA and BMAC, which raises concerns about the reliability of BMAC for clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Variability of Mesenchymal Stem Cells Obtained via Bone Marrow Aspirate Concentrate Compared With Traditional Bone Marrow Aspiration Technique. Brozovich, A., Sinicrope, BJ., Bauza, G., et al.[2022]

A single injection of Bone Marrow Aspirate Concentrate (BMAC) significantly improved knee osteoarthritis symptoms, showing better results in pain and function compared to a cycle of 4 Autologous Conditioned Serum (ACS) injections over a six-month follow-up.

Both BMAC and ACS treatments were found to be safe and effective, but BMAC demonstrated greater efficacy in reducing pain and improving function as measured by the WOMAC index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and functional evaluation of bone marrow aspirate concentrate vs autologous conditioned serum in the treatment of knee osteoarthritis. Vitali, M., Ometti, M., Pironti, P., et al.[2023]

Bone marrow aspirate concentrate (BMAC) shows promising efficacy in treating chondral defects and osteoarthritis of the knee, with all studies reporting good to excellent outcomes.

The procedure is considered safe, but the review highlights a lack of high-quality studies, indicating a need for more rigorous research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concentrated Bone Marrow Aspirate for the Treatment of Chondral Injuries and Osteoarthritis of the Knee: A Systematic Review of Outcomes. Chahla, J., Dean, CS., Moatshe, G., et al.[2022]

In a study of 55 patients with knee osteoarthritis, a single injection of autologous bone marrow aspirate concentrate (BMAC) led to significant improvements in patient-reported outcomes, including Tegner, VAS, and WOMAC scores.

The results suggest that BMAC is a beneficial and safe treatment option for knee osteoarthritis, as all measured outcomes showed statistically significant improvement from baseline to follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of bone marrow derived mesenchymal stem cells for the treatment of osteoarthritis: A retrospective long-term follow-up study. Mariani, C., Meneghetti, E., Zambon, D., et al.[2023]

In a study of 110 patients with knee osteoarthritis, both microfragmented adipose tissue (MFAT) and bone marrow aspirate concentrate (BMAC) injections led to significant improvements in pain and function, as measured by various questionnaires over a follow-up period averaging 1.8 years for BMAC and 1.1 years for MFAT.

There was no significant difference in the effectiveness of pain relief and functional improvement between the two treatment groups, indicating that both MFAT and BMAC are viable options for treating symptomatic knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Outcomes Following Microfragmented Adipose Tissue Versus Bone Marrow Aspirate Concentrate Injections for Symptomatic Knee Osteoarthritis. Mautner, K., Bowers, R., Easley, K., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38929594/

Effectiveness and Complications of Bone Marrow Aspirate ... BMAC is a reliable and effective treatment for patients with K-L grades II-III knee OA, but the orthopedic surgeon should consider that bleeding ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11206007/

Effectiveness and Complications of Bone Marrow Aspirate ... This study showed that BMAC treatment in patients with K–L grades II–III knee OA provides reliable and effective clinical outcomes over a 6- ...

3. nature.com nature.com/articles/s41598-024-51410-2

Intra-articular injection of bone marrow aspirate ... This is the first study on BMAC injections into 37 osteoarthritic knees with a 4-year follow up showing significant improvements in IKDC and WOMAC scores.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04716803

Bone Marrow Aspirate Concentrate (BMAC)Treatment for ... This is a pilot open-label, non-randomized, single institution study of BMAC administration in patient's with moderate to severe osteoarthritis of the knee who ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772594422001613

Bone marrow aspirate injection for osteoarthritis of the hip Patients with KL grade 4 showed significant improvement in pain at 12 months. Forty-two percent of patients at 6 months and 61% at 12 months reported ≥50% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12113016/

Bone Marrow Aspirate Concentrate (BMAC) for Knee ... BMAC is an autologous regenerative therapy enriched with mesenchymal stem cells (MSCs) and bioactive growth factors, offering potential disease-modifying ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11208346/

Safety and Efficacy of Bone-Marrow Aspirate Concentrate ... The results from this review demonstrated that administration of BMAC is safe and potentially efficacious in terms of reducing pain, improving function and ...