Osteoarthritis, KneePhase 1NCT05234489
Study to Assess Signature Cord Product in Patients With Symptomatic OA of the Knee
A Phase 1 study testing Signature Cord Prime in people with Osteoarthritis, Knee, run by Thomas Klootwyk, MD.
Trial summary
This study is a Phase 1 trial. The overall objective is to evaluate the safety and potential efficacy of a specific type of umbilical cord tissue-derived product (SIG001), which, other than a change in cryopreservation medium to render it compatible with cGMP, is similar to the reported real-world experience from 2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Signature Cord Prime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to Jun 2023
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of osteoarthritis of the knee based on clinical and radiographic findings
- Kellgren-Lawrence Grades 2-3
- Average pain score, on a 100-point numerical rating scale (VAS), over the past 7 days of > 40 and < 90 in the index knee and < 40 in the contralateral knee
- Body mass index < 35 kg/m²
- Ability to comply with the requirements of the study
- Ability to understand and provide written informed consent
- Not suspecting or expecting to be pregnant during the study period
- All participants of reproductive age/capacity to confirm the use of adequate contraception during the study period
Who cannot join
- Prior therapeutic radiation to the index knee
- Use of any pain medication or therapy less (anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDS) oral and topical, topical CBD, and narcotics) than 15 days prior to test product administration that has not or will not have had a stable dosage, frequency, or intensity for at least 3 months prior to test agent administration. Use of oral NSAIDs at a stable dose at least 3 months prior to test agent administration must be continued through the study period.
- Intra-articular treatment with corticosteroids, regenerative medicines (e.g., plasma, stem cell, placental products), or systemic steroid use within 3 months prior to screening
- Intra-articular treatment with hyaluronic acid within 6 months prior to screening
- Surgical intervention on the index knee < 12 months, or arthroscopy < 3 months prior to screening
- Non-ambulatory status
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- Past or current diagnosis of fibromyalgia or inflammatory arthritis, gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, active infection of the index knee joint or at the site of injection, pes anserine bursitis, neurogenic or vascular claudication, or uncontrolled diabetes mellitus (HbA1C>8%)
- Diagnosis of arthritis due to traumatic injury or meniscal tear in the index knee within 2 years of screening
- Moderate or large knee effusion in the index knee at screening and at test agent administration that requires drainage for diagnostic purposes or symptomatic relief
- Clinically significant, ongoing illness or medical condition that in the opinion of the investigator constitutes a safety risk for participation in the study or that could interfere with achieving the study objectives, conduct or evaluation
- Females who are pregnant or lactating
- Regular use of anticoagulants (daily use of aspirin ≦ 325 mg is acceptable)
- Active alcohol or substance abuse or any other reason that makes it unlikely that the subject will comply with study procedures
- Subjects with a psychiatric illness or condition, which, in the opinion of the investigation, would interfere with the conduct of the study or the interpretation of study results. Subjects with stable anxiety and depression defined as being on stable doses of antidepressant and anxiety drugs for the last 6 months and for which no dose changes are expected during the study can be included.
- Clinically significant medical, surgical, psychiatric, or laboratory abnormality that, in the judgment of the investigator, is likely to adversely affect the subject's risk-benefit or interfere with study compliance or assessment of safety or efficacy.
- Known allergy to local anesthetics or components of the study drug.
- Subjects with autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or Human Immunodeficiency Virus (HIV).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 1, Open-label, Dose-ranging Study to Assess the Safety, Tolerability, Preliminary Efficacy, and Dose Effect of Signature Cord Product in Patients With Symptomatic Osteoarthritis of the Knee
This study is a Phase 1 trial. The overall objective is to evaluate the safety and potential efficacy of a specific type of umbilical cord tissue-derived product (SIG001), which, other than a change in cryopreservation medium to render it compatible with cGMP, is similar to the reported real-world experience from 2 clinics on 135 knees.
Read the detailed description
Primary Objective:
A Phase 1, open-label, non-controlled trial, to assess the safety of intra-articular injection of SIG001, at either of two doses, in a total of 10 patients with Symptomatic Osteoarthritis of the Knee, Kellgren-Lawrence Grade 2-3, at 7, 30, 90 and 180 days after dosing.
Secondary Objective:
A Phase 1, open-label, non-controlled trial, to obtain very early data relating to any effects of intra-articular injection of SIG001, at either of two doses pain, activity, and quality of life in 10 patients with Symptomatic Osteoarthritis of the Knee, Kellgren-Lawrence Grade 2-3, at 7, 30, 90 and 180 days.
Study Design:
The Phase 1 trial will enroll 5 subjects into an initial group receiving a low dose of SIG001. Provided that these subjects tolerate this dose well, will proceed to enroll 5 subjects into a group receiving a high dose of SIG001.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Signature Cord Prime
- Keywords
- Allogeneic Umbilical Cord Tissue
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signature Cord PrimeBiological
Low dose - Subjects will receive SIG001 (75 mg) which will be diluted to a total of 4 ml volume with Ringer's Lactate.
High dose - Subjects will receive SIG001 (150mg) which will be diluted to a total of 4 ml volume with Ringer's Lactate.
| Study group | Role | What they receive |
|---|---|---|
| Low Dosage Group | Active comparator | This group will receive the lower dose (75mg) of the investigational product. Receives: Biological: Signature Cord Prime |
| High Dosage Group | Active comparator | This group will receive the higher dose (150mg) of the investigational product. Receives: Biological: Signature Cord Prime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of Signature Cord Prime as defined per CTCAE v. Stopping criteria as defined in 6.11.2.8
Administered as a single intra-articular injection in subjects with osteoarthritis of knee at 2 dose levels; 75mg and 150mg
Measured: 7 days
Evaluate the safety and tolerability of Signature Cord Prime as defined per CTCAE v. Stopping criteria as defined in 6.11.2.8
Administered as a single intra-articular injection in subjects with osteoarthritis of knee at 2 dose levels; 75mg and 150mg
Measured: 30 days
Evaluate the safety and tolerability of Signature Cord Prime as defined per CTCAE v. Stopping criteria as defined in 6.11.2.8
Administered as a single intra-articular injection in subjects with osteoarthritis of knee at 2 dose levels; 75mg and 150mg
Measured: 90 days
Secondary outcomes (5)
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Changes are the differences from the baseline:
Changes in overall WOMAC Score (WOMAC)
Measured: 90 days and six months
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Changes are the differences from the baseline:
Changes in overall KOOS Score (KOOS)
Measured: 90 days and six months
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Changes are the differences from the baseline:
Changes in patient-reported outcomes (PROs) (PROMIS-29)
Measured: 90 days and six months
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Changes are the differences from the baseline:
Changes in the Pain Visual Analog Scale (100 mm VAS)
Measured: 90 days and six months
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Changes are the differences from the baseline:
Use of opioid analgesic during study for the affected knee
Measured: 90 days and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Feb 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The Phase 1 trial will enroll 5 subjects into an initial group receiving a low dose of SIG001. Provided that these subjects tolerate this dose well, will proceed to enroll 5 subjects into a group receiving a high dose of SIG001.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Klootwyk, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Signature Biologics, LLC, KLM Solutions, LLC
- Responsible party
- Sponsor-investigator, Thomas Klootwyk, MD, Forte Sports Medicine and Orthopedics
- Investigators
- Thomas Klootwyk, MD, Principal investigator, Forte Sports Medicine and Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234489
- Sponsor's protocol ID
- SIG001-OAK-01
- Status last verified
- Feb 2022
- First submitted
- 7 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data is proprietary to the manufacturer and will not be shared outside of journal publications.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose-ranging Study to Assess the Safety, Tolerability, Preliminary Efficacy, and Dose Effect of Signature Cord Product in Patients With Symptomatic Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT05234489
- Acronym / sponsor ID
- SIG001-OAK-01
- Conditions
- Osteoarthritis, Knee
- Keywords
- Allogeneic Umbilical Cord Tissue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Thomas Klootwyk, MDUniversity, hospital or other
- Collaborators
- Signature Biologics, LLC, KLM Solutions, LLC
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 10 Feb 2022 (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.
This study is a Phase 1 trial. The overall objective is to evaluate the safety and potential efficacy of a specific type of umbilical cord tissue-derived product (SIG001), which, other than a change in cryopreservation medium to render it compatible with cGMP, is similar to the reported real-world experience from 2 clinics on 135 knees.
Detailed description
Primary Objective:
A Phase 1, open-label, non-controlled trial, to assess the safety of intra-articular injection of SIG001, at either of two doses, in a total of 10 patients with Symptomatic Osteoarthritis of the Knee, Kellgren-Lawrence Grade 2-3, at 7, 30, 90 and 180 days after dosing.
Secondary Objective:
A Phase 1, open-label, non-controlled trial, to obtain very early data relating to any effects of intra-articular injection of SIG001, at either of two doses pain, activity, and quality of life in 10 patients with Symptomatic Osteoarthritis of the Knee, Kellgren-Lawrence Grade 2-3, at 7, 30, 90 and 180 days.
Study Design:
The Phase 1 trial will enroll 5 subjects into an initial group receiving a low dose of SIG001. Provided that these subjects tolerate this dose well, will proceed to enroll 5 subjects into a group receiving a high dose of SIG001.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Phase 1 trial will enroll 5 subjects into an initial group receiving a low dose of SIG001. Provided that these subjects tolerate this dose well, will proceed to enroll 5 subjects into a group receiving a high dose of SIG001.
| Arm | Type | Receives |
|---|---|---|
| Low Dosage Group | Active comparator | Biological: Signature Cord PrimeThis group will receive the lower dose (75mg) of the investigational product. |
| High Dosage Group | Active comparator | Biological: Signature Cord PrimeThis group will receive the higher dose (150mg) of the investigational product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of osteoarthritis of the knee based on clinical and radiographic findings
- Kellgren-Lawrence Grades 2-3
- Average pain score, on a 100-point numerical rating scale (VAS), over the past 7 days of > 40 and < 90 in the index knee and < 40 in the contralateral knee
- Body mass index < 35 kg/m²
- Ability to comply with the requirements of the study
Key exclusion criteria (17 listed)
- Prior therapeutic radiation to the index knee
- Use of any pain medication or therapy less (anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDS) oral and topical, topical CBD, and narcotics) than 15 days prior to test product administration that has not or will not have had a stable dosage, frequency, or intensity for at least 3 months prior to test agent administration. Use of oral NSAIDs at a stable dose at least 3 months prior to test agent administration must be continued through the study period.
- Intra-articular treatment with corticosteroids, regenerative medicines (e.g., plasma, stem cell, placental products), or systemic steroid use within 3 months prior to screening
- Intra-articular treatment with hyaluronic acid within 6 months prior to screening
- Surgical intervention on the index knee < 12 months, or arthroscopy < 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 |
|---|---|---|
| Signature Cord PrimeLow dose - Subjects will receive SIG001 (75 mg) which will be diluted to a total of 4 ml volume with Ringer's Lactate. High dose - Subjects will receive SIG001 (150mg) which will be diluted to a total of 4 ml volume with Ringer's Lactate. | Biological | High Dosage Group, Low Dosage Group |
Primary outcome
Evaluate the safety and tolerability of Signature Cord Prime as defined per CTCAE v. Stopping criteria as defined in 6.11.2.8
Time frame: 7 days
Administered as a single intra-articular injection in subjects with osteoarthritis of knee at 2 dose levels; 75mg and 150mg
Evaluate the safety and tolerability of Signature Cord Prime as defined per CTCAE v. Stopping criteria as defined in 6.11.2.8
Time frame: 30 days
Administered as a single intra-articular injection in subjects with osteoarthritis of knee at 2 dose levels; 75mg and 150mg
Evaluate the safety and tolerability of Signature Cord Prime as defined per CTCAE v. Stopping criteria as defined in 6.11.2.8
Time frame: 90 days
Administered as a single intra-articular injection in subjects with osteoarthritis of knee at 2 dose levels; 75mg and 150mg
5 secondary outcomes
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Time frame: 90 days and six months
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Time frame: 90 days and six months
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Time frame: 90 days and six months
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Time frame: 90 days and six months
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Time frame: 90 days and six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Individual participant dataSharing planned: No. Data is proprietary to the manufacturer and will not be shared outside of journal publications.
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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.
Thomas Klootwyk, MD principal investigator
Forte Sports Medicine and Orthopedics
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Signature Cord Prime in people with Osteoarthritis, Knee, run by Thomas Klootwyk, MD.
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 8 inclusion and 17 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 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 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.
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 Chris Curless, MHA, LAT, ATC ((317) 817-1226, chris@msm-foundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of Signature Cord Prime as defined per CTCAE v. Stopping criteria as defined in 6.11.2.8 (time frame: 7 days). 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 10 Feb 2022.