RECRUITING

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

Conditions

Osteoarthritis of Knee Pain Treatment in Osteoarthritis (OA) of the Knee

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1/2a, Multicenter, Randomized, Controlled, Single-Blind, Dose-Finding Study to Evaluate the Safety and Efficacy of Cryopreserved Devitalized Adipose Tissue Allograft (BRC-OA) for Pain Treatment in Subjects With Mild to Severe Osteoarthritis (OA) of the Knee

Quick Facts

Study Start:2025-05-05

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06828666

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Males or females 18-80 years of age, inclusive 2. 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: 1. 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 2. Degenerative meniscal tears allowed as long as there are no pending surgeries 3. Flexion Contraction and Valgus/Varus deformity allowed if \< 10 degrees 3. 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: 1. Acetaminophen 2. NSAID (e.g., ibuprofen, naproxen) 3. Opioid (e.g., tramadol) 4. Topical NSAID (e.g., diclofenac gel) 5. Intra-articular injections (e.g., corticosteroids, hyaluronic acid) 4. 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 5. 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.	1. BMI greater than 40 kg/m2 2. Previous IA injections (e.g., corticosteroid, hyaluronic acid (HA), platelet rich plasma (PRP), etc.) into the index knee within 3 months prior to screening 3. Prior Partial Joint Replacement (PJR) or Total Joint Replacement (TJR) of one or both knees 4. Knee surgery in the previous 6 months prior to enrollment and/or planned knee surgery during the study 5. Symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee 6. Rapidly progressing osteoarthritis (RPOA) 7. Prior cartilage transplants in the index knee 8. Subjects who are actively treated with oral anticoagulants or heparin therapy (treatment such as low dose Aspirin and Plavix are allowed) 9. Current therapy with any immunosuppressive therapy, including corticosteroids (\> 5mg/day of prednisone) 10. Any method of medical marijuana use containing THC or CBD, including smoke or vaporized spray inhalation, pills or liquids, edible foods, topical applications, etc. 11. 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 12. Active alcohol or substance use disorder, or any other reason that would make it unlikely for the patient to comply with study procedures 13. 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) 14. Subject has known allergy to any components of BRC-OA 15. Subject has received an investigational product within 3 months before screening 16. Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient

Inclusion Criteria

Exclusion Criteria

1. Males or females 18-80 years of age, inclusive
2. 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:
1. 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
2. Degenerative meniscal tears allowed as long as there are no pending surgeries
3. Flexion Contraction and Valgus/Varus deformity allowed if \< 10 degrees
3. 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:
1. Acetaminophen
2. NSAID (e.g., ibuprofen, naproxen)
3. Opioid (e.g., tramadol)
4. Topical NSAID (e.g., diclofenac gel)
5. Intra-articular injections (e.g., corticosteroids, hyaluronic acid)
4. 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
5. 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.

1. BMI greater than 40 kg/m2
2. Previous IA injections (e.g., corticosteroid, hyaluronic acid (HA), platelet rich plasma (PRP), etc.) into the index knee within 3 months prior to screening
3. Prior Partial Joint Replacement (PJR) or Total Joint Replacement (TJR) of one or both knees
4. Knee surgery in the previous 6 months prior to enrollment and/or planned knee surgery during the study
5. Symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee
6. Rapidly progressing osteoarthritis (RPOA)
7. Prior cartilage transplants in the index knee
8. Subjects who are actively treated with oral anticoagulants or heparin therapy (treatment such as low dose Aspirin and Plavix are allowed)
9. Current therapy with any immunosuppressive therapy, including corticosteroids (\> 5mg/day of prednisone)
10. Any method of medical marijuana use containing THC or CBD, including smoke or vaporized spray inhalation, pills or liquids, edible foods, topical applications, etc.
11. 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
12. Active alcohol or substance use disorder, or any other reason that would make it unlikely for the patient to comply with study procedures
13. 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)
14. Subject has known allergy to any components of BRC-OA
15. Subject has received an investigational product within 3 months before screening
16. Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient

Contacts and Locations

Study Contact

Molly Saunders

CONTACT

301-467-8763

msaunders@britecyte.com

Matthew Gaver

CONTACT

240-454-6833

matthewg@amarexcro.com

Principal Investigator

Molly Saunders

STUDY_DIRECTOR

Sr. Director, Regenerative Medicine Programs

Study Locations (Sites)

LifeBridge Health

Baltimore, Maryland, 21215

United States

The Osteoporosis & Clinical Trials Center

Hagerstown, Maryland, 21740

United States

MD Medical Research

Oxon Hill, Maryland, 20745

United States

Northwell Health

New York, New York, 10065

United States

University Orthopedics Center

Altoona, Pennsylvania, 16602

United States

University Orthopedics Center

State College, Pennsylvania, 16801

United States

Collaborators and Investigators

Sponsor: Britecyte

Molly Saunders, STUDY_DIRECTOR, Sr. Director, Regenerative Medicine Programs

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-05

Study Completion Date2026-04

Study Record Updates

Study Start Date2025-05-05

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

Pain Treatment in Osteoarthritis (OA) of the Knee

Additional Relevant MeSH Terms

Osteoarthritis of Knee