Osteoarthritis, KneePhase 2NCT04612023
An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2 mL Injection) and a Placebo (Sterile Saline) in the Treatment of Osteoarthritis of the Knee
A Phase 2 study testing Acellular Amniotic Membrane Derived Allograft Injection (NuDYN) in people with Osteoarthritis, Knee, run by Illinois Center for Orthopaedic Research and Education at 1 site in United States.
Trial summary
The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft for the treatment of knee osteoarthritis and to confirm whether the use of 2 mL of the same amniotic injection offers a statistically significant advantage over the 1 mL injection when… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2020to 2 Jul 2022
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a candidate for non-surgical intervention of the knee
- Patient must be between the ages of 21 and 80 years old
- Patient must have a diagnosis of osteoarthritis (OA) of the knee defined as grade 1 to 3 on the Kellgren-Lawrence grading scale
Who cannot join
- Patient has a diagnosis of osteoarthritis with a Kellgren-Lawrence grade of 4
- Patient has a BMI greater than 40 kg/m2, active infection at the injection site, symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol) and requires other therapy
- Patient has rheumatoid arthritis, psoriatic arthritis or diagnosis with any other disorder that is the primary source of their knee pain
- Patient has an autoimmune disease or known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
- Patient has any of the following treatments to the target knee within 12 weeks prior to screening
- Intra-articular hyaluronic acid (HA) injection
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- Steroid or platelet rich plasma (PRP) injection
- Use of any investigational drug, device, or biologic
- Patient had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
- Patient has a history of partial or total knee arthroplasty
- Patient has undergone immunotherapy or chemotherapy in the last 5 years, prior radiation at the site, or is currently taking a narcotic medication for any reason
- Patient is pregnant or plans to become pregnant within 365 days of treatment
- Patient has any significant medical condition that would interfere with protocol evaluation and participation
- Patient is a recipient of worker's compensation
- Patient is a current prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
ICORE
Westmont, Illinois, 60559
Ronak M Patel, MD, 630-929-2249, rpatel@ibji.com
Eyal Ginesin, MD, 6309292249, eginesin@ibji.com
About this study
Official title: A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Allograft Injection Comparing Two Doses (1 mL and 2mL Injection) and a Placebo (Sterile Saline) in the Treatment of Osteoarthritis of the Knee
The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft for the treatment of knee osteoarthritis and to confirm whether the use of 2 mL of the same amniotic injection offers a statistically significant advantage over the 1 mL injection when compared to a placebo.
Read the detailed description
It is a prospective, double blinded, Randomized Controlled Trial study. Data will be prospectively collected of all injectable acellular amniotic membrane derived allograft knee performed at our institute (1 vs 2 mL).
90 subjects will be enrolled in the study. Subjects will be randomized 1:1:1 in treatment arms.
It compares the dose affect of an amniotic membrane allograft between a 1 mL dose and a 2 mL dose when compared to a placebo of sterile saline in the treatment of osteoarthritis of the knee. This will be offered as a free pain management alternative to patients who meet the inclusion criteria. The results will be determined by validated patient-reported outcome tools (KOOS, VAS, and WOMAC questionnaires) and physical examinations taken before the injection, one month after the injection, three months after the injection, six months after the injection, and one year after the injection. There will be a phone call 24 hours after the injection for every patient participating in the study regarding any potential adverse events.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)
- Keywords
- osteoarthritis, amniotic fluid, amniotic allograft, knee, amniotic membrane
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)Other
Injectable acellular amniotic membrane derived allograft tissue (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) to a placebo (sterile saline) in the treatment of knee osteoarthritis. Injection is minimally invasive and is FDA regulated (HCT/P regulation).
| Study group | Role | What they receive |
|---|---|---|
| 1 mL NyDYN Injection | Active comparator | 30 patients (out of 90) will be blind to and randomly assigned to a 1 mL NyDYN injection. Receives: Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN) |
| 2 mL NuDYN Injection | Active comparator | 30 patients (out of 90) will be blind to and randomly assigned to a 2 mL NyDYN injection. Receives: Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN) |
| Placebo of Sterile Saline | Placebo comparator | 30 patients (out of 90) will be blind to and randomly assigned to a 2 mL dose of sterile saline. Receives: Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Knee injury and Osteoarthritis Outcome Score (KOOS)- assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: 1 year
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- assess the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. it is a 0 (worst)-96 scale (best).
Measured: 1 year
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.
Measured: 1 year
Secondary outcomes (3)
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Change from baseline Knee injury and Osteoarthritis Outcome Score (KOOS)- assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: 30, 90, 180, 365 days
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- assess the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. it is a 0 (worst)-96 scale (best).
Measured: 30, 90, 180, 365 days
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Change from baseline Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.
Measured: 30, 90, 180, 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start18 Nov 2020
- Primary completion2 Apr 2022 (estimated)
- Study completion2 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Model description
- Data will be prospectively collected on all injectable acellular amniotic membrane derived allograft knee performed at our institute. (FDA regulated - HCT/P regulation) Inclusion criteria will be all patients age between 21 and 80 years with a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale. Methods for collecting data will be through validated patient-reported outcome tools that the patient will complete pre-injection and at specified time intervals after injection: 30 days, 90 days, 180 days and 365 days. Patient will receive a phone call 24 hours after the injection to monitor any immediate potential adverse events.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Illinois Center for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyal Ginesin, Illinois Center for Orthopaedic Research and Education
- Investigators
- Nikil Chari, Study chair, Research AssistantJacob Barnhart, Study chair, Research Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612023
- Sponsor's protocol ID
- 8212
- Status last verified
- Feb 2021
- First submitted
- 27 Oct 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications. Am J Sports Med. 2016 Sep;44(9):2425-34. doi: 10.1177/0363546515612750. Epub 2015 Nov 19.
PubMed 26585668Vines JB, Aliprantis AO, Gomoll AH, Farr J. Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. J Knee Surg. 2016 Aug;29(6):443-50. doi: 10.1055/s-0035-1569481. Epub 2015 Dec 18.
PubMed 26683979
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Allograft Injection Comparing Two Doses (1 mL and 2mL Injection) and a Placebo (Sterile Saline) in the Treatment of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT04612023
- Acronym / sponsor ID
- 8212
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, amniotic fluid, amniotic allograft, knee, amniotic membrane
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Illinois Center for Orthopaedic Research and EducationUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 2 Apr 2022 (estimated)
- Study completion
- 2 Jul 2022 (estimated)
- First posted
- 2 Nov 2020 (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 determine the dose effect of a single injectable acellular amniotic membrane derived allograft for the treatment of knee osteoarthritis and to confirm whether the use of 2 mL of the same amniotic injection offers a statistically significant advantage over the 1 mL injection when compared to a placebo.
Detailed description
It is a prospective, double blinded, Randomized Controlled Trial study. Data will be prospectively collected of all injectable acellular amniotic membrane derived allograft knee performed at our institute (1 vs 2 mL).
90 subjects will be enrolled in the study. Subjects will be randomized 1:1:1 in treatment arms.
It compares the dose affect of an amniotic membrane allograft between a 1 mL dose and a 2 mL dose when compared to a placebo of sterile saline in the treatment of osteoarthritis of the knee. This will be offered as a free pain management alternative to patients who meet the inclusion criteria. The results will be determined by validated patient-reported outcome tools (KOOS, VAS, and WOMAC questionnaires) and physical examinations taken before the injection, one month after the injection, three months after the injection, six months after the injection, and one year after the injection. There will be a phone call 24 hours after the injection for every patient participating in the study regarding any potential adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Data will be prospectively collected on all injectable acellular amniotic membrane derived allograft knee performed at our institute. (FDA regulated - HCT/P regulation) Inclusion criteria will be all patients age between 21 and 80 years with a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale. Methods for collecting data will be through validated patient-reported outcome tools that the patient will complete pre-injection and at specified time intervals after injection: 30 days, 90 days, 180 days and 365 days. Patient will receive a phone call 24 hours after the injection to monitor any immediate potential adverse events.
| Arm | Type | Receives |
|---|---|---|
| 1 mL NyDYN Injection | Active comparator | Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)30 patients (out of 90) will be blind to and randomly assigned to a 1 mL NyDYN injection. |
| 2 mL NuDYN Injection | Active comparator | Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)30 patients (out of 90) will be blind to and randomly assigned to a 2 mL NyDYN injection. |
| Placebo of Sterile Saline | Placebo comparator | Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)30 patients (out of 90) will be blind to and randomly assigned to a 2 mL dose of sterile saline. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is a candidate for non-surgical intervention of the knee
- Patient must be between the ages of 21 and 80 years old
- Patient must have a diagnosis of osteoarthritis (OA) of the knee defined as grade 1 to 3 on the Kellgren-Lawrence grading scale
Key exclusion criteria (15 listed)
- Patient has a diagnosis of osteoarthritis with a Kellgren-Lawrence grade of 4
- Patient has a BMI greater than 40 kg/m2, active infection at the injection site, symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol) and requires other therapy
- Patient has rheumatoid arthritis, psoriatic arthritis or diagnosis with any other disorder that is the primary source of their knee pain
- Patient has an autoimmune disease or known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
- Patient has any of the following treatments to the target knee within 12 weeks 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 |
|---|---|---|
| Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)Injectable acellular amniotic membrane derived allograft tissue (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) to a placebo (sterile saline) in the treatment of knee osteoarthritis. Injection is minimally invasive and is FDA regulated (HCT/P regulation). | Other | 1 mL NyDYN Injection, 2 mL NuDYN Injection, Placebo of Sterile Saline |
Primary outcome
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Time frame: 1 year
Knee injury and Osteoarthritis Outcome Score (KOOS)- assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Time frame: 1 year
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- assess the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. it is a 0 (worst)-96 scale (best).
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Time frame: 1 year
Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.
3 secondary outcomes
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Time frame: 30, 90, 180, 365 days
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Time frame: 30, 90, 180, 365 days
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Time frame: 30, 90, 180, 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Background: PubMed 26585668Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications. Am J Sports Med. 2016 Sep;44(9):2425-34. doi: 10.1177/0363546515612750. Epub 2015 Nov 19.
- Background: PubMed 26683979Vines JB, Aliprantis AO, Gomoll AH, Farr J. Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. J Knee Surg. 2016 Aug;29(6):443-50. doi: 10.1055/s-0035-1569481. Epub 2015 Dec 18.
- 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.
Nikil Chari study chair
Research Assistant
Jacob Barnhart study chair
Research Assistant
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 Acellular Amniotic Membrane Derived Allograft Injection (NuDYN) in people with Osteoarthritis, Knee, run by Illinois Center for Orthopaedic Research and Education 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 3 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 15 Feb 2021. 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 Eyal Ginesin, MD (6309292249, eginesin@ibji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT04612023, which also lists 2 linked publications.
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 15 Feb 2021; AzTrials last refreshed its copy on 28 Oct 2026.