NCT03337243

Brief Summary

The purpose of this study is to compare the pain, functioning and pain medication consumption of knee osteoarthritis (OA) patients who have allogenic cytokines derived from human amniotic membranes (HAM) and allogenic mesenchymal stem cells derived from human umbilical cord Wharton's Jelly (HUMCWJ) implanted into the affected knee with knee OA patients who self-select to be in a non-intervention control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 9, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2019

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

1.5 years

First QC Date

May 25, 2017

Last Update Submit

May 5, 2020

Conditions

Knee OsteoarthritisKnee Pain ChronicJoint DiseaseArthritisOsteo Arthritis KneeMusculoskeletal Disease

Keywords

Stem Cell InjectionCytokineWharton's JellyStem Cells

Outcome Measures

Primary Outcomes (4)

  • Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) over 3 months

    Baseline (T0), 4 weeks (T1), 3 months (T2)

  • Change in pain during sit-to-stand over 3 months

    Participants will perform as many sit-to-stand movements as they can in 30 seconds and then will rate pain

    Baseline (T0), 4 weeks (T1), 3 months (T2)

  • Change in pain during supine to upright over 3 months

    Participants will perform a supine to upright movement as quickly as they can and then will rate pain

    Baseline (T0), 4 weeks (T1), 3 months (T2)

  • Change in pain during ascent/decent stairs over 3 months

    Participants will ascend and decent 10 stairs as quickly as they can and then will rate pain

    Baseline (T0), 4 weeks (T1), 3 months (T2)

Study Arms (2)

HAM and HUMCWJ Injections (Group 1)

EXPERIMENTAL

Participants who self-select into the Group 1 (Immediate Treatment) will be scheduled to undergo the HAM and HUMCWJ injections to the OA affected knee at the same visit.

Procedure: HAM and HUMCWJ Injections

Control (Group 2)

NO INTERVENTION

Participants who self-select into Group 2 will choose to delay their HAM and HUMCWJ injection to the OA affected knee for at least 3 months or choose not to have the injections at all. Participants will be asked to keep track of pain management and therapy throughout the 3 months.

Interventions

HAM and HUMCWJ InjectionsPROCEDURE

SURGENEX SurForce® (1cc) allograft placental based tissue matrix, will be injected using a 22 gauge, 2-inch needle. The injection site (medial, lateral, patellar) will be determined based on the side with the most joint space from the findings of the most recent x-rays. The Physician will insert the needle fully into the joint space and begin to expel the fluid. He will achieve a continuous injection flow as he withdraws the needle back out of joint space. Immediately following the SURGENEX SurForce® injection, an injection of Predictive Biotech CORECYTE(TM) (1 cc) allograft umbilical cord-derived Warton's Jelly tissue matrix will be administered. This will be done using the exact same protocol as the SURGENEX SurForce® injection.

HAM and HUMCWJ Injections (Group 1)

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • knee OA patients who are eligible for HAM and HUMCWJ therapy of their knee, no previous HAM or HUMCWJ therapy, between the ages of 50-85, independently residing in the community, no previously diagnosed cognitive decline or mental illness, and not taking pain medication more than once per week for a condition other than knee OA

You may not qualify if:

  • Allergy to or use of penicillin, streptomycin, emphotericin B or dimethylsulfoxide. DMSO allergies and any immunocompromised conditions will also be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scott Medical Health Center

Pittsburgh, Pennsylvania, 15220, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeJoint DiseasesArthritisMusculoskeletal Diseases

Interventions

ATF7IP protein, human

Condition Hierarchy (Ancestors)

OsteoarthritisRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Chiropractic

Study Record Dates

First Submitted

May 25, 2017

First Posted

November 8, 2017

Study Start

November 9, 2017

Primary Completion

April 26, 2019

Study Completion

April 26, 2019

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)