Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Hip
Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Hip
1 other identifier
interventional
4,000
1 country
1
Brief Summary
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 hip. Follow-up will consist of a larger sample including 4,000 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2015
Longer than P75 for phase_2
1 active site
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
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 8, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
October 14, 2025
October 1, 2025
11.1 years
July 8, 2016
October 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change is being assessed for the HOOS survey (Hip Osteoarthritis Outcome Scores)
Hip Osteoarthritis Outcome Scores
0,2,6 months
Secondary Outcomes (3)
Change is being assessed by MRI of afflicted joint
0 and (6 months optional)
Change is being assessed for the SF36 survey (Short Form Quality of Life Survey)
0,2,6 months
Change is being assessed for the NRS survey (Numerical Rating Scale for Pain)
0,2,6 months
Study Arms (1)
StroMed + Platelet Rich plasma [PRP]
EXPERIMENTALBecause no enzymes or drugs are added with this mechanical process, the resulting (StroMed) cell concentrate still contains the extra-cellular matrix. In addition, the cells have not been altered by manipulation with enzymes or culturing. This autologous, cell concentrate is of minimal risk to the patient with no artificial ingredients added. Additional treatments with Platelet Rich Plasma (PRP) processed by the RegenLab (RegenKit BCT-3) PRP product by direct injection to affected joints.
Interventions
Patients will be treated with autologous StroMed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints at the time of initial treatment. Thereafter the affected joints will be treated with direct injections to the joint with Platelet Rich Plasma processed by RegenLab (RegenKit BCT-3) PRP product. Day 0 \[StroMed + platelet rich plasma (PRP)\], Day 7, 14 and 30 \[PRP\]
Eligibility Criteria
You may qualify if:
- Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
- Patients range from 18-90 years of age.
- Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
- Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
- Patients with adequate cardiac and respiratory function.
- Patients with adequate blood coagulation activity, PT(INR) \< 1.5, APTT
- Patients must have adequate immune system function, with no known immunodeficiency disease.
- Greater than 6 months hip pain with the index side (left or right).
You may not qualify if:
- Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
- Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke).
- Diagnosis of a transient ischemic attack in the 6 months prior to screening.
- Patients infected with hepatitis B, C or HIV.
- Patients with Body Mass Index (BMI) \> 40kg/m2
- Presence of active infection.
- 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.
- Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to:
- Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than hip osteoarthritis
- Corticosteroid injection at treatment site within 1 month
- Consistent use of NSAIDs within 48 hours of procedure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VivaTech International, Inc.
Grove City, Pennsylvania, 16127, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark LoDico, MD
Advanced Regenerative Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2016
First Posted
July 26, 2016
Study Start
July 1, 2015
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
October 14, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share
Vivatech will monitor data and decide if/when data can be shared