Osteoarthritis of KneePhase 1/2NCT06828666
A Phase 1/2a to Evaluate the Safety and Efficacy of Adipose Tissue Allograft (BRC-OA) in Patients With Osteoarthritis of the Knee
A Phase 1/2 study testing Cryopreserved Devitalized Adipose Tissue Allograft in people with Osteoarthritis of Knee, run by Britecyte at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Cryopreserved Devitalized Adipose Tissue Allograft
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 May 2025to 15 Aug 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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)
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- 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
- Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University Orthopedics Center
Altoona, Pennsylvania, 16602
LifeBridge Health
Baltimore, Maryland, 21215
The Osteoporosis & Clinical Trials Center
Hagerstown, Maryland, 21740
Northwell Health
New York, New York, 10065
MD Medical Research
Oxon Hill, Maryland, 20745
Elevate Clinical Research
Rockville, Maryland, 20874
University Orthopedics Center
State College, Pennsylvania, 16801
About this study
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
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.
Read the detailed description
The study will be conducted in two parts:
- Part 1 (Safety Evaluation phase) - without control arm
- Part 2 (Randomized Controlled phase) - with control arm
In Part 1, six subjects will be treated with a 7-day staggering interval between each subject's enrollment. The initial 3 subjects will receive a 2 mL dose of BRCOA, and if deemed safe and well-tolerated by the investigator, the next 3 subjects will receive an 8 mL dose, also following a 7-day staggering interval to assess safety and tolerability. Once both dose levels (2 mL and 8 mL) are confirmed to be safe and tolerable, the study will advance to Part 2. In Part 2, a total of 36 subjects (12 subjects per arm) will be randomized 1:1:1 to three parallel arms to be administered via intraarticular injection of 2 mL or 8 mL of BRC-OA, or 2 mL of normal saline (control).
- Conditions
- Osteoarthritis of Knee
- Being tested
- Cryopreserved Devitalized Adipose Tissue Allograft, Normal Saline (Placebo)
- Keywords
- Pain Treatment in Osteoarthritis (OA) of the Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryopreserved Devitalized Adipose Tissue AllograftBiological
BRC-OA is a Cryopreserved Devitalized Adipose Tissue Allograft that has demonstrated anti-inflammatory and antioxidant properties of adipose tissue.
Normal Saline (Placebo)Other
2 mL Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - 2 mL of BRC-OA via intra-articular injection | Experimental | Not described Receives: Biological: Cryopreserved Devitalized Adipose Tissue Allograft |
| Part 1 - 8 mL of BRC-OA via intra-articular injection | Experimental | Not described Receives: Biological: Cryopreserved Devitalized Adipose Tissue Allograft |
| Part 2 - 2 mL of BRC-OA via intra-articular injection | Experimental | Not described Receives: Biological: Cryopreserved Devitalized Adipose Tissue Allograft |
| Part 2 - 8 mL of BRC-OA via intra-articular injection | Experimental | Not described Receives: Biological: Cryopreserved Devitalized Adipose Tissue Allograft |
| Part 2 - 2 mL of Normal Saline via intra-articular injection | Sham comparator | Not described Receives: Other: Normal Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Outcome Measures
- Incidence and severity of local and systemic treatment-emergent adverse events (TEAEs) and SAEs
Measured: From Baseline to 6 months
Primary Safety Outcome Measures
- Incidence of abnormal laboratory panel and vital signs (Baseline to 6 months)
Measured: 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.
Measured: From Baseline and 3 months
Secondary outcomes (8)
Secondary Efficacy Outcome Measures
- WOMAC VAS Pain Scale - difference in change from Baseline and 1 week, 6 weeks, and 6 months
Measured: Baseline to 6 months
Secondary Efficacy Outcome Measures
- WOMAC VAS Stiffness and Function Scales - difference in change from Baseline and 1 week, 6 weeks, 3 months, and 6 months
Measured: Baseline to 6 months
Secondary Efficacy Outcome Measures
- WOMAC VAS Total Score - difference in change from Baseline and 1 week, 6 weeks, 3 months, and 6 months
Measured: Baseline to 6 months
Secondary Efficacy Outcome Measures
- KOOS-12 Pain, Function, and Quality of Life Scales - difference in change from Baseline and 1 week, 6 weeks, 3 months, and 6 months
Measured: Baseline to 6 months
Secondary Efficacy Outcome Measures
- KOOS-12 Summary Impact Score - difference in change from Baseline and 1 week, 6 weeks, 3 months, and 6 months
Measured: Baseline to 6 months
Secondary Efficacy Outcome Measures
- SF-12 Questionnaire - difference in change from Baseline and 3 months
Measured: Baseline and 3 months
Secondary Efficacy Outcome Measures
- Six-Minute Walk Test - difference in score from Baseline and 3 months and 6 months
Measured: Baseline to 6 months
Secondary Efficacy Outcome Measures
- Rescue Treatments - percentage of subjects using rescue treatments from baseline to 1 week, 6 weeks, 3 months, and 6 months
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start5 May 2025
- Primary completion15 Feb 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted in two parts: * Part 1 (Safety Evaluation phase) - without control arm * Part 2 (Randomized Controlled phase) - with control arm
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Britecyte
- Sponsor type
- Research network
- Collaborators
- Amarex Clinical Research
- Responsible party
- Sponsor
- Investigators
- Alla Danilkovitch, Study director, Founder & Chief Scientific Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828666
- Sponsor's protocol ID
- 241
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06828666
- Acronym / sponsor ID
- 241
- Conditions
- Osteoarthritis of Knee
- Keywords
- Pain Treatment in Osteoarthritis (OA) of the Knee
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- BritecyteResearch network
- Collaborators
- Amarex Clinical Research
- Study start
- 5 May 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be conducted in two parts:
- Part 1 (Safety Evaluation phase) - without control arm
- Part 2 (Randomized Controlled phase) - with control arm
In Part 1, six subjects will be treated with a 7-day staggering interval between each subject's enrollment. The initial 3 subjects will receive a 2 mL dose of BRCOA, and if deemed safe and well-tolerated by the investigator, the next 3 subjects will receive an 8 mL dose, also following a 7-day staggering interval to assess safety and tolerability. Once both dose levels (2 mL and 8 mL) are confirmed to be safe and tolerable, the study will advance to Part 2. In Part 2, a total of 36 subjects (12 subjects per arm) will be randomized 1:1:1 to three parallel arms to be administered via intraarticular injection of 2 mL or 8 mL of BRC-OA, or 2 mL of normal saline (control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- The study will be conducted in two parts: * Part 1 (Safety Evaluation phase) - without control arm * Part 2 (Randomized Controlled phase) - with control arm
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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:
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryopreserved Devitalized Adipose Tissue AllograftBRC-OA is a Cryopreserved Devitalized Adipose Tissue Allograft that has demonstrated anti-inflammatory and antioxidant properties of adipose tissue. | Biological | 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)2 mL Normal Saline | Other | Part 2 - 2 mL of Normal Saline via intra-articular injection |
Primary outcome
Primary Safety Outcome Measures
Time frame: From Baseline to 6 months
• Incidence and severity of local and systemic treatment-emergent adverse events (TEAEs) and SAEs
Primary Safety Outcome Measures
Time frame: From Baseline to 6 months
• Incidence of abnormal laboratory panel and vital signs (Baseline to 6 months)
Primary Efficacy Outcome Measure
Time frame: From Baseline and 3 months
• 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.
8 secondary outcomes
Secondary Efficacy Outcome Measures
Time frame: Baseline to 6 months
Secondary Efficacy Outcome Measures
Time frame: Baseline to 6 months
Secondary Efficacy Outcome Measures
Time frame: Baseline to 6 months
Secondary Efficacy Outcome Measures
Time frame: Baseline to 6 months
Secondary Efficacy Outcome Measures
Time frame: Baseline to 6 months
Secondary Efficacy Outcome Measures
Time frame: Baseline and 3 months
Secondary Efficacy Outcome Measures
Time frame: Baseline to 6 months
Secondary Efficacy Outcome Measures
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alla Danilkovitch study director
Founder & Chief Scientific Officer
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cryopreserved Devitalized Adipose Tissue Allograft in people with Osteoarthritis of Knee, run by Britecyte at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Outcome Measures (time frame: From Baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.