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Use of Senolytic and Anti-Fibrotic Agents to Improve the Beneficial Effect of Bone Marrow Stem Cells for Osteoarthritis

NCT04815902 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-04-16

No results posted yet for this study

Summary

This is a prospective, randomized, double-blind, active control clinical trial to evaluate the safety and efficacy of a senolytic agent (Fisetin) and an anti-fibrotic agent (Losartan), used independently and in combination, to improve beneficial effect demonstrated by the active control which is to be injection of autologous bone marrow aspirate concentrate (BMAC) into an osteoarthritic knee.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Fisetin

Oral Fisetin 20 mg/kg taken for 10 days total.

DRUG

Losartan

12.5 mg oral Losartan taken for 30 days total.

DRUG

Placebo - Losartan

Losartan appearance-matched microcrystalline cellulose placebo. 12.5 taken for 30 days total.

DRUG

Placebo Fisetin

Fisetin appearance-matched microcrystalline cellulose placebo. 20 mg/kg taken for 10 days total.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Steadman Philippon Research Institute

    lead OTHER

Principal Investigators

  • Johnny Huard, PhD · Steadman Philippon Research Institute

  • Marc Philippon, MD · Steadman Philippon Research Institute

  • Scott L Tashman, PhD · Steadman Philippon Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2025-02-01
Completion
2025-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04815902 on ClinicalTrials.gov