A Phase 1/2a to Evaluate the Safety and Efficacy of Adipose Tissue Allograft (BRC-OA) in Patients With Osteoarthritis of the Knee

NCT06828666 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 241
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Osteoarthritis of Knee

Keywords

Pain Treatment in Osteoarthritis (OA) of the Knee

Outcome Measures

Primary Outcomes (3)

• Primary Safety Outcome Measures

  • Incidence and severity of local and systemic treatment-emergent adverse events (TEAEs) and SAEs

  From Baseline to 6 months

• Primary Safety Outcome Measures

  • Incidence of abnormal laboratory panel and vital signs (Baseline to 6 months)

  From Baseline to 6 months

• Primary Efficacy Outcome Measure

  • WOMAC VAS Pain Scale - WOMAC (Western Ontario and McMaster Universities Arthritis Index) pain subscale consists of 5 individual questions. The VAS score is determined by measuring in millimeters from the left-hand end of the line to the point that the patient marks (0-100 mm) for 5 questions \[0 represents no knee pain, and 100 represents extreme knee pain\]. The results for each question are summed to calculate the total WOMAC pain subscale score ranging from a total of 0 to 500. The total WOMAC pain subscale score will be normalized/standardized on a scale from 0 to 100. A negative number for the change from baseline indicates a reduction in pain.

  From Baseline and 3 months

Secondary Outcomes (8)

• Secondary Efficacy Outcome Measures

  Baseline to 6 months

• Secondary Efficacy Outcome Measures

  Baseline to 6 months

• Secondary Efficacy Outcome Measures

  Baseline to 6 months

• Secondary Efficacy Outcome Measures

  Baseline to 6 months

• Secondary Efficacy Outcome Measures

  Baseline to 6 months

Other Outcomes (1)

• Additional Exploratory Outcome Measures

  Baseline and 3 months

Study Arms (5)

Part 1 - 2 mL of BRC-OA via intra-articular injection

EXPERIMENTAL

Biological: Cryopreserved Devitalized Adipose Tissue Allograft

Part 1 - 8 mL of BRC-OA via intra-articular injection

EXPERIMENTAL

Biological: Cryopreserved Devitalized Adipose Tissue Allograft

Part 2 - 2 mL of BRC-OA via intra-articular injection

EXPERIMENTAL

Biological: Cryopreserved Devitalized Adipose Tissue Allograft

Part 2 - 8 mL of BRC-OA via intra-articular injection

EXPERIMENTAL

Biological: Cryopreserved Devitalized Adipose Tissue Allograft

Part 2 - 2 mL of Normal Saline via intra-articular injection

SHAM COMPARATOR

Other: Normal Saline (Placebo)

Interventions

Cryopreserved Devitalized Adipose Tissue Allograft BIOLOGICAL

BRC-OA is a Cryopreserved Devitalized Adipose Tissue Allograft that has demonstrated anti-inflammatory and antioxidant properties of adipose tissue.

Part 1 - 2 mL of BRC-OA via intra-articular injection; Part 1 - 8 mL of BRC-OA via intra-articular injection; Part 2 - 2 mL of BRC-OA via intra-articular injection; Part 2 - 8 mL of BRC-OA via intra-articular injection

Normal Saline (Placebo) OTHER

2 mL Normal Saline

Part 2 - 2 mL of Normal Saline via intra-articular injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females 18-80 years of age, inclusive
• Diagnosis of OA in one or both knees supported by documentation of clinical and radiographic findings(KL Grades 2-4) up to 6 months prior to screening:
• Diagnosis of degenerative or post-traumatic OA of the knee supported by documentation of clinical and radiographic findings up to 6 months prior to screening
• Degenerative meniscal tears allowed as long as there are no pending surgeries
• Flexion Contraction and Valgus/Varus deformity allowed if \< 10 degrees
• Subject must have tried for at least 3 months and failed on at least two of the following pharmacological standard of care therapies in the past 12 months:
• Acetaminophen
• NSAID (e.g., ibuprofen, naproxen)
• Opioid (e.g., tramadol)
• Topical NSAID (e.g., diclofenac gel)
• Intra-articular injections (e.g., corticosteroids, hyaluronic acid)
• Subjects knee pain persists for at least 12 weeks prior to screening and does not improve with pain medications (e.g., NSAIDs, acetaminophen, tramadol, etc.) and/or other nonoperative treatment options
• Index knee WOMAC pain subscale score of ≥ 40 on a normalized/standardized scale of 0 to 100 at screening visit Note: The index knee in subjects with bilateral OA of the knees is the one with worse pain with walking. Where both knees have equal pain with walking, then the knee on the subject's dominant side will be designated the index knee.

You may not qualify if:

• BMI greater than 40 kg/m2
• Previous IA injections (e.g., corticosteroid, hyaluronic acid (HA), platelet rich plasma (PRP), etc.) into the index knee within 3 months prior to screening
• Prior Partial Joint Replacement (PJR) or Total Joint Replacement (TJR) of one or both knees
• Knee surgery in the previous 6 months prior to enrollment and/or planned knee surgery during the study
• Symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee
• Rapidly progressing osteoarthritis (RPOA)
• Prior cartilage transplants in the index knee
• Subjects who are actively treated with oral anticoagulants or heparin therapy (treatment such as low dose Aspirin and Plavix are allowed)
• Current therapy with any immunosuppressive therapy, including corticosteroids (\> 5mg/day of prednisone)
• Any method of medical marijuana use containing THC or CBD, including smoke or vaporized spray inhalation, pills or liquids, edible foods, topical applications, etc.
• Clinically significant intercurrent illness, medical condition, non-knee pain, or medical history that could jeopardize the patient safety, limit participation, or compromise interpretation of data derived from the patient; this includes neurological or mental illness, human immunodeficiency virus, fibromyalgia, complex regional pain syndrome, or any active infection - including hepatitis B or C
• Active alcohol or substance use disorder, or any other reason that would make it unlikely for the patient to comply with study procedures
• Females who are lactating or pregnant (positive pregnancy test for females of childbearing potential at screening Females of childbearing potential must be willing to use an acceptable method of contraception from screening up until 90 days after study drug injection administration Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, patch, injectable, depot, or vaginal) in conjunction with a barrier method (e.g., diaphragm, cervical cap, condom, spermicide, or sponge), or female subject/partner's use of an implantable device (implantable rod or intrauterine device)
• Subject has known allergy to any components of BRC-OA
• Subject has received an investigational product within 3 months before screening

Sponsors & Collaborators

• Britecyte: lead
• Amarex Clinical Research: collaborator

Study Sites (7)

LifeBridge Health

Baltimore, Maryland, 21215, United States

RECRUITING

The Osteoporosis & Clinical Trials Center

Hagerstown, Maryland, 21740, United States

RECRUITING

MD Medical Research

Oxon Hill, Maryland, 20745, United States

RECRUITING

Elevate Clinical Research

Rockville, Maryland, 20874, United States

RECRUITING

Northwell Health

New York, New York, 10065, United States

RECRUITING

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

RECRUITING

University Orthopedics Center

State College, Pennsylvania, 16801, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Molly Saunders

  Sr. Director, Regenerative Medicine Programs

  STUDY DIRECTOR

Central Study Contacts

Molly Saunders

CONTACT

301-467-8763; msaunders@britecyte.com

David Kuo

CONTACT

240-454-6822; davidk@amarexcro.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The study will be conducted in two parts: * Part 1 (Safety Evaluation phase) - without control arm * Part 2 (Randomized Controlled phase) - with control arm

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 14, 2025
• Study Start: May 5, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-02

Locations

US (7)