Adipose Tissue Allograft for Knee Arthritis

Recruiting at 6 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for knee arthritis to determine its safety and ability to reduce pain. The treatment involves injecting a special type of preserved fat tissue, called Cryopreserved Devitalized Adipose Tissue Allograft, directly into the knee. The trial will explore different doses to identify the most effective one. Individuals with knee arthritis pain unresponsive to common medications, such as painkillers or topical gels, might be suitable candidates for this trial. As a Phase 1, Phase 2 trial, the research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

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.

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

Research shows that treatments like BRC-OA, which use specially processed fat tissue, are under study for knee arthritis. This treatment aims to alleviate knee pain. Previous studies have examined the safety of BRC-OA in individuals with knee arthritis.

Since this trial is in its early stages, the main goal is to ensure the treatment's safety for humans. Researchers design these studies to assess whether the treatment is well-tolerated and to monitor for any side effects. Early trials focus on identifying potential risks and ensuring the treatment does not harm participants.

For those considering participation, it's important to know that while this treatment is still under testing, these early-phase trials are crucial steps in proving its safety for wider use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for knee arthritis?

Researchers are excited about using cryopreserved devitalized adipose tissue allograft for knee arthritis because it offers a novel approach compared to traditional treatments like NSAIDs, corticosteroid injections, or physical therapy. Unlike these standard options, this treatment uses adipose tissue, which is rich in regenerative properties, potentially offering a more natural and long-lasting solution. Additionally, the treatment is administered via intra-articular injection directly into the knee joint, which could provide targeted relief and reduce systemic side effects. This innovative method aims to harness the body's own healing mechanisms, potentially providing significant improvements in joint function and pain relief.

What evidence suggests that this cryopreserved devitalized adipose tissue allograft is effective for knee arthritis?

Research shows that using specially preserved fat tissue, such as BRC-OA, may help treat knee osteoarthritis (OA) by reducing pain and swelling. This trial will test different dosages of BRC-OA, with some participants receiving 2 mL and others 8 mL via intra-articular injection. Studies on similar treatments suggest these fat tissue grafts can help repair cartilage and improve joint function. Fat tissue, which includes fat cells, has qualities that might aid in joint healing and pain relief. While research continues, early results indicate benefits for people with mild to severe knee OA. ^{1 2 5 6 7}

Who Is on the Research Team?

Molly Saunders

Principal Investigator

Sr. Director, Regenerative Medicine Programs

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06828666

Study Details | NCT06828666 | A Phase 1/2a to Evaluate ... 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, ...

2. withpower.com withpower.com/trial/phase-2-osteoarthritis-3-2025-9ac47

Adipose Tissue Allograft for Knee Arthritis Research on similar treatments, like cryopreserved osteochondral allografts, shows encouraging results for knee cartilage defects, suggesting potential benefits ...

3. synapse.patsnap.com synapse.patsnap.com/organization/2ba09325c72a4a7a79aacacc5a914831

Britecyte Inc - Drug pipelines, Patents, Clinical trials ... Efficacy of Cryopreserved Devitalized Adipose Tissue Allograft (BRC-OA) for Pain Treatment in Subjects With Mild to Severe Osteoarthritis (OA) of the Knee.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12071781/

Adipose Tissue-Derived Therapies for Osteoarthritis Adipose tissue-derived therapies have great potential to promote cartilage regeneration, reduce inflammation, and improve joint function.

5. ichgcp.net ichgcp.net/clinical-trials-registry/NCT06828666

Cryopreserved Devitalized Adipose Tissue Allograft in ... 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, ...

6. fdaaa.trialstracker.net fdaaa.trialstracker.net/trial/NCT06828666/

NCT06828666: An ongoing trial by Britecyte Full data ; A Phase 1/2a, Multicenter, Randomized, Controlled, Single-Blind, Dose-Finding Study to Evaluate the Safety and Efficacy of Cryopreserved Devitalized ...

7. sigma.larvol.com sigma.larvol.com/facility.php?FacilityId=25247898

Blue Nine Systems Trials NCT06828666: A Phase 1/2a to Evaluate the Safety and Efficacy of Adipose Tissue Allograft (BRC-OA) in Patients With Osteoarthritis of the Knee. Recruiting. 1/2.