Osteoarthritis, KneePhase 2OANCT03441607
Safety & Efficacy FloGraft (Micronized Human Amnion Chorion Membrane)® in Adults With Pain Due to OA of the Knee
A Phase 2 study testing mHACMb in people with Osteoarthritis, Knee, run by Applied Biologics, LLC at 1 site in United States.
Trial summary
Safety \& Efficacy of FloGraft (Micronized Human Amnion Chorion Membrane)® in Adults With Pain Due to Osteoarthritis of the Knee. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- mHACMb
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2018to Mar 2019
- Phase
- Phase 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent to participate in the study.
- Willing and able to participate in all procedures and follow-up evaluations necessary to complete the study.
- Subject is 30 years or older.
- Moderate OA pain (rating of at least 20mm on the VAS) assessed at Baseline.
- Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale) assessed at Baseline.
- Must be ambulatory.
- No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an efficacy measure.
Who cannot join
- Subject has active infection at the injection site.
- Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
- BMI greater than 40 kg/m2.
- Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 3 months prior to screening.
- Subject has received an intra-articular amniotic fluid, amniotic membrane or amniotic fluid/membrane combination injection for the treatment of OA of the target knee within 3 months prior to screening.
- Subject has received a steroid, bone marrow aspirate concentrate (BMAC) or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 3 months prior to screening.
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- Subject has had major surgery, arthroplasty or arthroscopy in the target knee within 26 weeks of treatment or plans to have surgery in the target knee within 180 days of treatment.
- Subject is pregnant or plans to become pregnant within 180 days of treatment.
- Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
- Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
- Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin).
- Diagnosis of gout in the past 6 month.
- Major injury to the target knee within the 12 months prior to the screening.
- Severe hip osteoarthritis ipsilateral to the target knee.
- Any pain that could interfere with the assessment of the target knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety & Efficacy of Micronized Human Amnion Chorion Membrane Biologic (mHACMb) FloGraft (Micronized Human Amnion Chorion Membrane)® in Adults With Pain Due to Osteoarthritis of the Knee
Safety \& Efficacy of FloGraft (Micronized Human Amnion Chorion Membrane)® in Adults With Pain Due to Osteoarthritis of the Knee.
- Conditions
- Osteoarthritis, Knee
- Being tested
- mHACMb, placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHACMbDrug
Also called 40mg FloGraft (micronized human amnion chorion membrane)®, 100mg FloGraft (micronized human amnion chorion membrane)®
Active ingredient
placeboOther
Also called saline
inactive ingredient
| Study group | Role | What they receive |
|---|---|---|
| Drug | Active comparator | Intervention: 40 mg of micronized human amnion chorion membrane biologic (mHACMb); administered 1(x) on second visit; followed by 2 follow-up visits for assessment over a duration of 3 months. Receives: Drug: mHACMb |
| Placebo | Placebo comparator | Intervention: 1cc of saline will be administered as a one time injection on visit 2, administered 1(x) on first visit; followed by 2 follow-up visits for assessment over a duration of 3 months. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Decreased Pain Level
Measured: 3 Months
Secondary outcomes (1)
Western Ontario and McMaster Universities Arthritis Index (WOMAC®) osteoarthritis Index 3.1.
Decrease in pain, stiffness, and physical functioning of the joints.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study startNov 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Britt, Study director, Applied Biologics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441607
- Sponsor's protocol ID
- BX001
- Acronym
- OA
- Status last verified
- Sep 2018
- First submitted
- 7 Feb 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Efficacy of Micronized Human Amnion Chorion Membrane Biologic (mHACMb) FloGraft (Micronized Human Amnion Chorion Membrane)® in Adults With Pain Due to Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT03441607
- Acronym / sponsor ID
- OA / BX001
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Applied Biologics, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 22 Feb 2018 (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.
Safety \& Efficacy of FloGraft (Micronized Human Amnion Chorion Membrane)® in Adults With Pain Due to Osteoarthritis of the Knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Active comparator | Drug: mHACMbIntervention: 40 mg of micronized human amnion chorion membrane biologic (mHACMb); administered 1(x) on second visit; followed by 2 follow-up visits for assessment over a duration of 3 months. |
| Placebo | Placebo comparator | Other: placeboIntervention: 1cc of saline will be administered as a one time injection on visit 2, administered 1(x) on first visit; followed by 2 follow-up visits for assessment over a duration of 3 months. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to provide written informed consent to participate in the study.
- Willing and able to participate in all procedures and follow-up evaluations necessary to complete the study.
- Subject is 30 years or older.
- Moderate OA pain (rating of at least 20mm on the VAS) assessed at Baseline.
- Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale) assessed at Baseline.
Key exclusion criteria (15 listed)
- Subject has active infection at the injection site.
- Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
- BMI greater than 40 kg/m2.
- Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 3 months prior to screening.
- Subject has received an intra-articular amniotic fluid, amniotic membrane or amniotic fluid/membrane combination injection for the treatment of OA of the target knee within 3 months prior to screening.
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 |
|---|---|---|
| mHACMbAlso: 40mg FloGraft (micronized human amnion chorion membrane)®, 100mg FloGraft (micronized human amnion chorion membrane)®Active ingredient | Drug | Drug |
| placeboAlso: salineinactive ingredient | Other | Placebo |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 3 Months
Decreased Pain Level
1 secondary outcome
Western Ontario and McMaster Universities Arthritis Index (WOMAC®) osteoarthritis Index 3.1.
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Edward Britt study director
Applied Biologics, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mHACMb in people with Osteoarthritis, Knee, run by Applied Biologics, LLC at 1 site 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 7 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samantha Montgomery (602-325-1221 ext. 9825, samantha.montgomery@appliedbiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 3 Months). 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 28 Sep 2018.