RECRUITING

Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000 patients.

Official Title

Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Knee

Quick Facts

Study Start:2015-07

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02844751

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients with indication of Osteoarthritis, grade 2 or more. Can be from degeneration or chronic injury. 2. Patients range from 18-90 years of age. 3. Patients must be able to comply with treatment plan, laboratory tests and periodic interviews. 4. Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl. 5. Patients with adequate cardiac and respiratory function. 6. Patients with adequate blood coagulation activity, PT(INR) \< 1.5, APTT 7. Patients must have adequate immune system function, with no known immunodeficiency disease. 8. Greater than 6 months knee pain on the index side (left or right knee).	1. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision 2. Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke). 3. Diagnosis of a transient ischemic attack in the 6 months prior to screening. 4. Patients infected with hepatitis B, C or HIV. 5. Patients with Body Mass Index (BMI) \> 40kg/m2 6. Presence of active infection. 7. Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study. 8. Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to: 1. Knee instability. 2. A varus/valgus deformity of more than 10o, a deformity requiring osteotomy or complex surgery. 3. Gout or pseudo gout 4. Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than knee osteoarthritis 5. Corticosteroid injection at treatment site within 1 month 6. Consistent use of NSAIDs within 48 hours of procedure.

Inclusion Criteria

Exclusion Criteria

1. Patients with indication of Osteoarthritis, grade 2 or more. Can be from degeneration or chronic injury.
2. Patients range from 18-90 years of age.
3. Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
4. Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
5. Patients with adequate cardiac and respiratory function.
6. Patients with adequate blood coagulation activity, PT(INR) \< 1.5, APTT
7. Patients must have adequate immune system function, with no known immunodeficiency disease.
8. Greater than 6 months knee pain on the index side (left or right knee).

1. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
2. Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke).
3. Diagnosis of a transient ischemic attack in the 6 months prior to screening.
4. Patients infected with hepatitis B, C or HIV.
5. Patients with Body Mass Index (BMI) \> 40kg/m2
6. Presence of active infection.
7. Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study.
8. Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to:
1. Knee instability.
2. A varus/valgus deformity of more than 10o, a deformity requiring osteotomy or complex surgery.
3. Gout or pseudo gout
4. Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than knee osteoarthritis
5. Corticosteroid injection at treatment site within 1 month
6. Consistent use of NSAIDs within 48 hours of procedure.

Contacts and Locations

Study Contact

Scott M Herkes, MBA

CONTACT

855-984-8287

scott.herkes@gmail.com

Michael P Hutchinson, DVM

CONTACT

412-503-3788

drmike@vivatechusa.com

Principal Investigator

Mark LoDico, MD

PRINCIPAL_INVESTIGATOR

Advanced Regenerative Medicine

Study Locations (Sites)

VivaTech International, Inc.

Grove City, Pennsylvania, 16127

United States

Collaborators and Investigators

Sponsor: VivaTech International, Inc.

Mark LoDico, MD, PRINCIPAL_INVESTIGATOR, Advanced Regenerative Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-07

Study Completion Date2025-08

Study Record Updates

Study Start Date2015-07

Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

Osteoarthritis