Adipose Tissue Allograft for Knee Arthritis

Recruiting at 5 trial locations

Overseen By Matthew Gaver

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Britecyte

Must not be taking: Anticoagulants, Immunosuppressives, Marijuana, others

Disqualifiers: BMI > 40, Knee surgery, others

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

Compensation: Varies

Number of Visits: 9

42 Participants Needed

Trial Summary

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

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on certain treatments like oral anticoagulants, high-dose corticosteroids, or medical marijuana. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Cryopreserved Devitalized Adipose Tissue Allograft for knee arthritis?

Research on similar treatments, like cryopreserved osteochondral allografts, shows encouraging results for knee cartilage defects, suggesting potential benefits for knee arthritis. However, fresh grafts have shown better outcomes than cryopreserved ones, indicating that while cryopreservation is promising, it may not be as effective as fresh tissue. ^{1 2 3 4 5}

Is the use of adipose tissue allograft for knee arthritis safe?

Studies show that using adipose tissue (fat tissue) for treating knee arthritis is generally safe, with no adverse effects reported in patients up to 1 year after treatment. ^{6 7 8 9 10}

How is the treatment of cryopreserved devitalized adipose tissue allograft for knee arthritis different from other treatments?

This treatment is unique because it uses cryopreserved devitalized adipose tissue, which may provide cushioning and support tissue regeneration through stem cells, unlike traditional treatments that do not utilize these regenerative properties. ^{6 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to evaluate the safety profile of BRC-OA for pain treatment in patients with mild to severe OA of the knee, focusing particularly on two distinct doses. Alongside safety assessments, the study also aims to investigate the initial efficacy of BRC-OA in treating pain among these patients. The study product is a cryopreserved devitalized adipose tissue allograft (BRC-OA). BRC-OA is composed of a devitalized human adipose particulate that retains the inherent properties of adipose such as tissue architecture, extracellular matrix, and signaling molecules.

Research Team

Molly Saunders

Principal Investigator

Sr. Director, Regenerative Medicine Programs

Eligibility Criteria

This trial is for men and women aged 18-80 with mild to severe knee osteoarthritis, including those with degenerative or post-traumatic conditions. Participants can have certain deformities if less than 10 degrees and must not be planning any knee surgeries. They should have tried standard pain treatments like acetaminophen or NSAIDs.

Inclusion Criteria

I have received joint injections like cortisone or hyaluronic acid.

I have knee osteoarthritis diagnosed within the last 6 months.

I have a torn meniscus but don't need surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Evaluation

Part 1: Safety evaluation of BRC-OA with staggered dosing to assess safety and tolerability

6 weeks

Weekly visits for 6 weeks

Randomized Controlled

Part 2: Randomized controlled phase with three parallel arms to evaluate efficacy and safety

3 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Visits at 3 and 6 months

Treatment Details

Interventions

• Cryopreserved Devitalized Adipose Tissue Allograft

Trial Overview The study tests BRC-OA, a cryopreserved tissue from human fat designed to retain beneficial properties for treating knee pain in osteoarthritis patients. It compares two doses of BRC-OA against a saline placebo to assess safety and initial effectiveness in reducing pain.

Participant Groups

Group I: Part 2 - 8 mL of BRC-OA via intra-articular injection Experimental Treatment 1 Intervention

Group II: Part 2 - 2 mL of BRC-OA via intra-articular injection Experimental Treatment 1 Intervention

Group III: Part 1 - 8 mL of BRC-OA via intra-articular injection Experimental Treatment 1 Intervention

Group IV: Part 1 - 2 mL of BRC-OA via intra-articular injection Experimental Treatment 1 Intervention

Group V: Part 2 - 2 mL of Normal Saline via intra-articular injection Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Britecyte

Lead Sponsor

Trials

1

Recruited

40+

Amarex Clinical Research

Collaborator

Trials

28

Recruited

1,700+

Findings from Research

In a study of 19 patients with full-thickness cartilage defects in the knee, treatment with cryopreserved osteochondral allografts led to significant improvements in knee function and quality of life, as shown by increases in various clinical outcome scores over an average follow-up of 41.9 months.

Despite positive outcomes, the study reported a reoperation rate of 21.1%, indicating that while the treatment can be effective, there is a notable risk of complications, particularly in patients with more complex (bipolar) cartilage lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Outcomes of Cryopreserved Osteochondral Allograft for Patellofemoral Cartilage Defects at Minimum 2-Year Follow-up. Melugin, HP., Ridley, TJ., Bernard, CD., et al.[2022]

Osteochondral allografts, especially fresh ones, have shown promising results in treating full-thickness cartilage defects in the knee, indicating their efficacy in clinical settings.

There is increasing interest in using cryopreserved grafts due to their potential for better tissue banking and the ability to overcome delays in obtaining fresh grafts, supported by encouraging laboratory data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteochondral allografts in the treatment of articular cartilage injuries of the knee. Hennig, A., Abate, J.[2018]

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 87 patients with knee osteoarthritis, a single injection of concentrated autologous adipose tissue significantly reduced pain and improved knee function, with 67 patients reporting pain relief.

The treatment was generally safe, with no major adverse effects reported, although some patients experienced mild swelling post-injection and five required knee replacement surgery within months of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of knee osteoarthritis by intra-articular injection of concentrated autologous adipose tissue: a twenty four month follow-up study. Bistolfi, A., Roato, I., Fornelli, G., et al.[2021]

In a study of 110 knees, a single ultrasound-guided injection of microfragmented adipose tissue (MFAT) significantly reduced pain (VAS score improved from 70 to 30) and enhanced functionality (OKS score improved from 25 to 33.5) in patients with knee osteoarthritis over a 12-month period.

No adverse events were reported during or after the procedure, indicating that MFAT injections are a safe treatment option for knee osteoarthritis, with promising improvements in patient quality of life (EQ-5D score improved from 0.62 to 0.69).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Outcomes of Microfragmented Adipose Tissue Treatments of Knee Osteoarthritis: An Observational, Intention-to-Treat Study at Twelve Months. Heidari, N., Noorani, A., Slevin, M., et al.[2022]

References

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

Prospective Outcomes of Cryopreserved Osteochondral Allograft for Patellofemoral Cartilage Defects at Minimum 2-Year Follow-up. [2022]

2. Brazil pubmed.ncbi.nlm.nih.gov

Allograft of the knee extensor in cases of patellar tendon rupture in total arthroplasty patients. [2022]

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

Osteochondral allografts in the treatment of articular cartilage injuries of the knee. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Predictors of Meniscal Allograft Transplantation Outcome: A Systematic Review. [2022]

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

Clinical comparison of freeze-dried and fresh frozen patellar tendon allografts for anterior cruciate ligament reconstruction of the knee. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Autologous micro-fragmented adipose tissue for the treatment of diffuse degenerative knee osteoarthritis: an update at 3 year follow-up. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

The use of intra-articular injection of autologous micro-fragmented adipose tissue as pain treatment for ankle osteoarthritis: a prospective not randomized clinical study. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A Worldwide Analysis of Adipose-Derived Stem Cells and Stromal Vascular Fraction in Orthopedics: Current Evidence and Applications. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Treatment of knee osteoarthritis by intra-articular injection of concentrated autologous adipose tissue: a twenty four month follow-up study. [2021]

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

Patient-Centered Outcomes of Microfragmented Adipose Tissue Treatments of Knee Osteoarthritis: An Observational, Intention-to-Treat Study at Twelve Months. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Autologous micro-fragmented adipose tissue associated with arthroscopy in moderate-severe knee osteoarthritis: outcome at two year follow-up. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

Autologous and micro-fragmented adipose tissue for the treatment of diffuse degenerative knee osteoarthritis. [2020]

14. Germany pubmed.ncbi.nlm.nih.gov

Successful isolation of viable stem cells from cryopreserved microfragmented human adipose tissue from patients with knee osteoarthritis - a comparative study of isolation by tissue explant culture and enzymatic digestion. [2023]