NCT04719793

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

January 14, 2021

Last Update Submit

July 20, 2022

Conditions

Osteoarthritis, Knee

Keywords

Knee OsteoarthritisUmbilical CordWharton's Jelly

Outcome Measures

Primary Outcomes (40)

  • Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by Comprehensive metabolic profile

    1week

  • Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by Comprehensive metabolic profile

    6weeks

  • Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by Comprehensive metabolic profile

    3months

  • Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by Comprehensive metabolic profile

    6months

  • Treatment-emergent adverse effects as assessed by Comprehensive Metabolic Profile

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by Comprehensive metabolic profile

    1year

  • Treatment-emergent adverse effects as assessed by creatinine levels

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by creatinine levels

    1week

  • Treatment-emergent adverse effects as assessed by creatinine levels

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by creatinine levels

    6weeks

  • Treatment-emergent adverse effects as assessed by creatinine levels

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by creatinine levels

    3months

  • Treatment-emergent adverse effects as assessed by creatinine levels

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by creatinine levels

    6months

  • Treatment-emergent adverse effects as assessed by creatinine levels

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by creatinine levels

    1year

  • Treatment-emergent adverse effects as assessed by liver function tests

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by liver function tests

    1week

  • Treatment-emergent adverse effects as assessed by liver function tests

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by liver function tests

    6weeks

  • Treatment-emergent adverse effects as assessed by liver function tests

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by liver function tests

    3months

  • Treatment-emergent adverse effects as assessed by liver function tests

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by liver function tests

    6months

  • Treatment-emergent adverse effects as assessed by liver function tests

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by liver function tests

    1year

  • Treatment-emergent adverse effects as assessed by complete blood count

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by complete blood count

    1week

  • Treatment-emergent adverse effects as assessed by complete blood count

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by complete blood count

    6weeks

  • Treatment-emergent adverse effects as assessed by complete blood count

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by complete blood count

    3months

  • Treatment-emergent adverse effects as assessed by complete blood count

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by complete blood count

    6months

  • Treatment-emergent adverse effects as assessed by complete blood count

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by complete blood count

    1year

  • Treatment-emergent adverse effects as assessed by C-reactive protein

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by C-reactive protein

    1week

  • Treatment-emergent adverse effects as assessed by C-reactive protein

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by C-reactive protein

    6weeks

  • Treatment-emergent adverse effects as assessed by C-reactive protein

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by C-reactive protein

    3months

  • Treatment-emergent adverse effects as assessed by C-reactive protein

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by C-reactive protein

    6months

  • Treatment-emergent adverse effects as assessed by C-reactive protein

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by C-reactive protein

    1year

  • Treatment-emergent adverse effects as assessed by erythrocyte sedimentation rate

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by erythrocyte sedimentation rate

    1week

  • Treatment-emergent adverse effects as assessed by erythrocyte sedimentation rate

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by erythrocyte sedimentation rate

    6weeks

  • Treatment-emergent adverse effects as assessed by erythrocyte sedimentation rate

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by erythrocyte sedimentation rate

    3months

  • Treatment-emergent adverse effects as assessed by erythrocyte sedimentation rate

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by erythrocyte sedimentation rate

    6months

  • Treatment-emergent adverse effects as assessed by erythrocyte sedimentation rate

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by erythrocyte sedimentation rate

    1year

  • Treatment-emergent adverse effects as assessed by T, B and NK cell lymphocyte subsets

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by T, B and NK cell lymphocyte subsets

    1week

  • Treatment-emergent adverse effects as assessed by T, B and NK cell lymphocyte subsets

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by T, B and NK cell lymphocyte subsets

    6weeks

  • Treatment-emergent adverse effects as assessed by T, B and NK cell lymphocyte subsets

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by T, B and NK cell lymphocyte subsets

    3months

  • Treatment-emergent adverse effects as assessed by T, B and NK cell lymphocyte subsets

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by T, B and NK cell lymphocyte subsets

    6months

  • Treatment-emergent adverse effects as assessed by T, B and NK cell lymphocyte subsets

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by T, B and NK cell lymphocyte subsets

    1year

  • Treatment-emergent adverse effects as assessed by serum IgG, IgA, IgM and IgE levels

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by serum IgG, IgA, IgM and IgE levels

    1week

  • Treatment-emergent adverse effects as assessed by serum IgG, IgA, IgM and IgE levels

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by serum IgG, IgA, IgM and IgE levels

    6weeks

  • Treatment-emergent adverse effects as assessed by serum IgG, IgA, IgM and IgE levels

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by serum IgG, IgA, IgM and IgE levels

    3months

  • Treatment-emergent adverse effects as assessed by serum IgG, IgA, IgM and IgE levels

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by serum IgG, IgA, IgM and IgE levels

    6months

  • Treatment-emergent adverse effects as assessed by serum IgG, IgA, IgM and IgE levels

    To determine safety i.e. adverse events associated with intraarticular administration of Umbilical cord-derived Wharton's Jelly as assessed by serum IgG, IgA, IgM and IgE levels

    1year

Secondary Outcomes (27)

  • 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

    Change from baseline to 24hours after injection

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

    Change from baseline to 48hours after injection

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

    Change from baseline to 1week after injection

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

    Change from baseline to 6weeks after injection

  • +22 more secondary outcomes

Study Arms (1)

Wharton's Jelly

EXPERIMENTAL

Intraarticular injection of Umbilical Cord-derived Wharton's Jelly

Biological: Umbilical Cord-derived Wharton's Jelly

Interventions

Umbilical Cord-derived Wharton's JellyBIOLOGICAL

Intraarticular injection

Wharton's Jelly

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be 18 years or older.
  • Must have a body mass index (BMI) of \< 40Kg/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 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 15 days (except Acetaminophen), 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gupta A, Maffulli N, Rodriguez HC, Lee CE, Levy HJ, El-Amin SF 3rd. Umbilical cord-derived Wharton's jelly for treatment of knee osteoarthritis: study protocol for a non-randomized, open-label, multi-center trial. J Orthop Surg Res. 2021 Feb 18;16(1):143. doi: 10.1186/s13018-021-02300-0.

    PMID: 33602286DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

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

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

Ashim Gupta, PhD, MBA

CONTACT

agupta@biointegrate.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 22, 2021

Study Start

January 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share