REcycled CartiLage Auto/Allo IMplantation

NCT03672825 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 18-000939
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is an FDA phase I study to evaluate the safety of allogeneic culture-expanded adipose-derived mesenchymal stem cells (AMSCs) combined with autologous cartilage cells to treat focal knee cartilage defects in one stage surgery.

Conditions

Cartilage Defect

Outcome Measures

Primary Outcomes (1)

• Nature, incidence and severity of adverse events (AEs)

  Defined as any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship.

  2 years

Study Arms (1)

RECLAIM

EXPERIMENTAL

Treating cartilage defects with autologous (your own) cartilage cells mixed with allogeneic (from someone else) adipose-derived mesenchymal stem cells (AMSCs).

Drug: REcycled CartiLage Auto/Allo IMplantation

Interventions

REcycled CartiLage Auto/Allo IMplantation DRUG

Treating cartilage defects with autologous (your own) cartilage cells mixed with allogeneic (from someone else) adipose-derived mesenchymal stem cells (AMSCs).

Also known as: RECLAIM

RECLAIM

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Pregnant or nursing, or planning on becoming pregnant during the study period
• Congenital or acquired malformation of the target knee resulting in significant deformity or leading to problems with the study treatment or analysis of the results
• Significant knee malalignment that is not corrected at the time of RECLAIM surgery.
• Injections of any kind into the target knee within 3 months prior to study enrollment
• History of intra-articular infection in the target knee
• History of superficial infection in the target knee within 6 months of study enrollment, or evidence of current superficial infection affecting the target knee
• History of falls requiring medical attention, or gait instability
• Clinically significant abnormal hematology (complete blood count with differential), blood chemistry, or urinalysis screening laboratory results.
• Body mass index (BMI) \> 35 kg/m2
• Taking anticoagulant medications (e.g. warfarin, heparin or clopidogrel) which may pose a clinically-significant contraindication to surgical RECLAIM therapy
• Taking herbal therapies or supplements within 4 weeks of enrollment or unwilling to avoid use of herbal therapies or supplements until at least 30 days following completion of the RECLAIM treatment cycle (includes, but not limited to chondroitin sulfate, diacerein, n-glucosamine, piascledine, and capsaicin)
• Taking non-steroidal anti-inflammatory medications (e.g. COX-2 inhibitors) without a stable dosing regimen for at least 4 weeks before baseline evaluation, or anticipating not remaining on a stable dose until at least 30 days following completion of the study drug treatment cycle
• Use of electrotherapy or acupuncture for knee pain, unless there is a stable regimen for at least 4 weeks before baseline assessment
• Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment
• On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Aaron J Krych

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: September 13, 2018
• Primary Completion: May 9, 2024
• Study Completion: June 21, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

US (1)