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

Trial Summary

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.

What data supports the effectiveness of the treatment Stem Cell Injections for Osteoarthritis?

Some studies suggest that bone marrow aspirate concentrate (BMAC), which is rich in mesenchymal stem cells, may be a promising treatment for knee osteoarthritis, showing potential benefits in reducing symptoms and improving joint function. ^{1 2 3 4 5}

Is stem cell injection therapy safe for treating osteoarthritis?

The studies reviewed suggest that treatments like Bone Marrow Aspirate Concentrate (BMAC) and microfragmented adipose tissue (MFAT) injections are generally safe for use in humans with osteoarthritis, as they showed significant improvements in quality of life and pain without major safety concerns reported. ^{1 3 6 7 8}

How is the treatment using stem cell injections for osteoarthritis different from other treatments?

This treatment uses bone marrow aspirate concentrate (BMAC) and lipoaspirate concentrate, which are rich in growth factors and stem cells that may help reduce inflammation and promote tissue repair in osteoarthritis. Unlike traditional treatments that mainly focus on pain relief, this approach aims to address the underlying joint damage. ^{8 9 10 11 12}

What is the purpose of this trial?

The purpose of this trial is to compare the effect of a single intra-articular injection of Lipoaspirate Concentrate vs Bone Marrow Aspirate on pain reduction and functional improvement in the treatment of the knee and hip OA.

Research Team

Grigory Karmy, MD

Principal Investigator

McMaster University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

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

High Variability of Mesenchymal Stem Cells Obtained via Bone Marrow Aspirate Concentrate Compared With Traditional Bone Marrow Aspiration Technique. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Clinical outcome of autologous bone marrow aspirates concentrate (BMAC) injection in degenerative arthritis of the knee. [2022]

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

A Prospective, Single-Blind, Placebo-Controlled Trial of Bone Marrow Aspirate Concentrate for Knee Osteoarthritis. [2022]

5. India 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. [2023]

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

Functional Outcomes Following Microfragmented Adipose Tissue Versus Bone Marrow Aspirate Concentrate Injections for Symptomatic Knee Osteoarthritis. [2020]

7. Italy pubmed.ncbi.nlm.nih.gov

Clinical and functional evaluation of bone marrow aspirate concentrate vs autologous conditioned serum in the treatment of knee osteoarthritis. [2023]

8. United States 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. [2022]

9. United States 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. [2022]

10. England 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. [2022]

11. United States 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. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Bone marrow concentrate injections for the treatment of osteoarthritis: evidence from preclinical findings to the clinical application. [2022]