Study to Assess Signature Cord Product in Patients With Symptomatic OA of the Knee

NCT05234489 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: SIG001-OAK-01
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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 clinics on 135 knees.

Conditions

Osteoarthritis, Knee

Keywords

Allogeneic Umbilical Cord Tissue

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  90 days

Secondary Outcomes (5)

• Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline

  90 days and six months

• Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline

  90 days and six months

• Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline

  90 days and six months

• Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline

  90 days and six months

• Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline

  90 days and six months

Study Arms (2)

Low Dosage Group

ACTIVE COMPARATOR

This group will receive the lower dose (75mg) of the investigational product.

Biological: Signature Cord Prime

High Dosage Group

ACTIVE COMPARATOR

This group will receive the higher dose (150mg) of the investigational product.

Biological: Signature Cord Prime

Interventions

Signature Cord Prime BIOLOGICAL

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.

High Dosage Group; Low Dosage Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Thomas Klootwyk, MD: lead
• Signature Biologics, LLC: collaborator
• KLM Solutions, LLC: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Thomas Klootwyk, MD

  Forte Sports Medicine and Orthopedics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Curless, MHA, LAT, ATC

CONTACT

(317) 817-1226; chris@msm-foundation.org

Thomas Klootwyk, MD

CONTACT

(317) 817-1200; tklootwyk@methodistsports.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopedic Surgeon

Model Details: 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 Record Dates

• First Submitted: January 7, 2022
• First Posted: February 10, 2022
• Study Start: February 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share