Evaluation of Safety and Efficacy of Wharton's Jelly Compared to Hyaluronic Acid and Saline for Knee Osteoarthritis.

NCT04711304 | Not Yet Recruiting Phase 1

• 1 other identifier: BIOINT - 2020WJ/OA
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the safety and efficacy of intraarticular injection of umbilical cord derived Wharton's Jelly compared to hyaluronic acid and saline for treatment of knee osteoarthritis symptoms.

Conditions

Osteoarthritis, Knee

Keywords

Knee Osteoarthritis, Umbilical Cord, Wharton's Jelly

Outcome Measures

Primary Outcomes (16)

• Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine safety i.e. Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly injection. Any adverse or severe adverse events will be recorded in the associated case report forms.

  Immediately after injection

• Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine safety i.e. Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly injection. Any adverse or severe adverse events will be recorded in the associated case report forms.

  24hours after injection

• Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine safety i.e. Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly injection. Any adverse or severe adverse events will be recorded in the associated case report forms.

  48hours after injection

• Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine safety i.e. Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly injection. Any adverse or severe adverse events will be recorded in the associated case report forms.

  1week after injection

• Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine safety i.e. Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly injection. Any adverse or severe adverse events will be recorded in the associated case report forms.

  6weeks after injection

• Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine safety i.e. Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly injection. Any adverse or severe adverse events will be recorded in the associated case report forms.

  3Months after injection

• Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine safety i.e. Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly injection. Any adverse or severe adverse events will be recorded in the associated case report forms.

  6Months after injection

• Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine safety i.e. Adverse or severe adverse events associated with intraarticular administration of umbilical cord-derived Wharton's Jelly injection. Any adverse or severe adverse events will be recorded in the associated case report forms.

  1Year after injection

• Patient Satisfaction associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine patient satisfaction via 7-point Likert Scale. An increase in score indicates improvement.

  1week after injection

• Patient Satisfaction associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine patient satisfaction via 7-point Likert Scale. An increase in score indicates improvement.

  6weeks after injection

• Patient Satisfaction associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine patient satisfaction via 7-point Likert Scale. An increase in score indicates improvement.

  3Months after injection

• Patient Satisfaction associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine patient satisfaction via 7-point Likert Scale. An increase in score indicates improvement.

  6Months after injection

• Patient Satisfaction associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine patient satisfaction via 7-point Likert Scale. An increase in score indicates improvement.

  1Year after injection

• Patient Satisfaction associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine patient satisfaction via 36-item short form survey (SF36)

  Change from baseline to 3Months after injection

• Patient Satisfaction associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine patient satisfaction via 36-item short form survey (SF36)

  Change from baseline to 6Months after injection

• Patient Satisfaction associated with intraarticular administration of umbilical cord-derived Wharton's Jelly

  To determine patient satisfaction via 36-item short form survey (SF36)

  Change from baseline to 1Year after injection

Secondary Outcomes (23)

• Change in patient reported outcome measures, Numeric Pain Rating Scale

  Change from baseline to immediately after injection

• Change in patient reported outcome measures, Numeric Pain Rating Scale

  Difference between groups (Wharton's Jelly, Hyaluronic Acid and Saline) in changes score for NPRS from baseline and immediately after injection

• Change in patient reported outcome measures, Numeric Pain Rating Scale

  Change from baseline to 24hours after injection

• Change in patient reported outcome measures, Numeric Pain Rating Scale

  Difference between groups (Wharton's Jelly, Hyaluronic Acid and Saline) in changes score for NPRS from baseline and 24hours after injection

• Change in patient reported outcome measures, Numeric Pain Rating Scale

  Change from baseline to 48hours after injection

Study Arms (3)

Wharton's Jelly

EXPERIMENTAL

Intraarticular injection of Wharton's Jelly

Biological: Umbilical Cord-derived Wharton's Jelly

Hyaluronic Acid

ACTIVE COMPARATOR

Intraarticular injection of Hyaluronic Acid

Device: Hyaluronic acid

Saline

PLACEBO COMPARATOR

Intraarticular injection of Saline

Other: Saline

Interventions

Umbilical Cord-derived Wharton's Jelly BIOLOGICAL

Intraarticular injection

Wharton's Jelly

Hyaluronic acid DEVICE

Intraarticular injection

Hyaluronic Acid

Saline OTHER

Intraarticular injection

Saline

Eligibility Criteria

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

You may qualify if:

• Patients must be 18 years or older.
• Must have a body mass index (BMI) of \< 50Kg/m2.
• Must be able to comply with the requirements of study visits.
• Diagnosed with mild to moderate knee osteoarthritis (OA) in one knee only - Grade 2 or 3 on the Kellgren Lawrence (KL) grading scale.
• Pain score of 4 or more on the NPRS (on scale of 0 to 10).
• Female patients were abstinent, surgically sterilized or postmenopausal.
• Premenopausal females with negative pregnancy test, and who does not anticipate pregnancy and will actively practice an accepted contraceptive method for the duration of study.
• Males with premenopausal female partners, will take contraceptive measures for the duration of study.
• Be willing and capable of giving written informed consent to participate in this clinical study.
• Be willing and capable of complying with study-related requirements, procedures and visits.

You may not qualify if:

• Patients who have taken any pain medications including NSAIDs within 2 weeks, prior to the study injection date, regularly use anticoagulants, substance abuse history, and/or failure to agree not to take any knee-symptom modifying drugs during the course of the study without discussing and reporting the use to site principal investigator and study team.
• Patients who are positive on special tests and stability tests on the physical exam case report form.
• Patients with intraarticular injection of any drug including corticosteroids, viscosupplementation in the index knee in last 3 months.
• Patients with index knee surgery within last 6 months.
• Patients with traumatic injury to index knee within last 3 months.
• Patients with planned elective surgery during the course of the study.
• Patients with organ or hematologic transplantation history, rheumatoid arthritis or other autoimmune disorders.
• Patients on immunosuppressive medication/treatment, diagnosis of non-basal cell carcinoma within last 5 years.
• Patients with knee infection or who used antibiotics for knee infection within last 3 months.
• Female patients who are breast feeding or are pregnant or desire to be pregnant during the course of the study.
• Patients with contraindication to X-ray or MRI imaging.
• Patients with serious neurological, psychological or psychiatric disorders.
• Patients with other medical conditions determined by site principal investigator as interfering with the study.
• Patients with an injury or disability claim under current litigation or pending or approved workers' compensation claim.

Sponsors & Collaborators

• BioIntegrate: lead

Related Publications (1)

• Gupta A, Maffulli N, Rodriguez HC, Carson EW, Bascharon RA, Delfino K, Levy HJ, El-Amin SF 3rd. Safety and efficacy of umbilical cord-derived Wharton's jelly compared to hyaluronic acid and saline for knee osteoarthritis: study protocol for a randomized, controlled, single-blind, multi-center trial. J Orthop Surg Res. 2021 May 31;16(1):352. doi: 10.1186/s13018-021-02475-6.

  PMID: 34059080 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Saadiq F. El-Amin III, MD, PhD

  El-Amin Orthopaedic & Sports Medicine Institute

  PRINCIPAL INVESTIGATOR

• Ashim Gupta, PhD, MBA

  BioIntegrate

  STUDY DIRECTOR

Central Study Contacts

Saadiq F. El-Amin III, MD, PhD

CONTACT

678-257-7078; dr.saadiqelamin@gmail.com

Ashim Gupta, PhD, MBA

CONTACT

agupta@biointegrate.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: January 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share