NCT05789719

Brief Summary

A phase 1 exploratory clinical study to investigate safety, tolerance and efficacy of a single intra-articular injection of autoSTEM-OA or alloSTEM-OA in participants with mild to moderate knee osteoarthritis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 16, 2023

Last Update Submit

March 16, 2023

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • STEM-OA safety

    Number of treatment emergent adverse events (TEAEs)

    13 weeks

Secondary Outcomes (2)

  • Knee pain

    13 weks

  • Number of treatment responders

    13 weks

Study Arms (6)

autoSTEM-OA 400

EXPERIMENTAL

400x10\^6 autologous MSC(AT)s in autologous fat

Biological: STEM-OA

alloSTEM-OA 400

EXPERIMENTAL

400x10\^6 allogeneic MSC(AT)s in autologous fat

Biological: STEM-OA

autoSTEM-OA 800

EXPERIMENTAL

800x10\^6 autologous MSC(AT)s in autologous fat

Biological: STEM-OA

alloSTEM-OA 800

EXPERIMENTAL

800x10\^6 allogeneic MSC(AT)s in autologous fat

Biological: STEM-OA

autoSTEM-OA 1600

EXPERIMENTAL

1600x10\^6 autologous MSC(AT)s in autologous fat

Biological: STEM-OA

alloSTEM-OA 1600

EXPERIMENTAL

1600x10\^6 allogeneic MSC(AT)s in autologous fat

Biological: STEM-OA

Interventions

STEM-OABIOLOGICAL

Combination of autologous or allogeneic MSC(AT)s and fat

alloSTEM-OA 1600alloSTEM-OA 400alloSTEM-OA 800autoSTEM-OA 1600autoSTEM-OA 400autoSTEM-OA 800

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • Male or female, aged 18 - 60 years (both inclusive) at the time of informed consent.
  • Joint pain ≥ 30mm on 100mm VAS at screening
  • Grade 2-3 Kellgren Lawrence OA on radiograph with no full-thickness lesion \>1 cm in any dimension by x-ray
  • Failure of minimum 2 nonoperative therapies (oral pain medications, physical therapy, corticosteroid injection, or viscosupplementation injection)
  • Body mass index (BMI) within the range 18 - 35 kg/m2 (both inclusive)
  • Minimum 200 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs as judged by the investigator.
  • Agree to donate cells to alloSTEM-OA participants.
  • Fulfils eligibility criteria for allogeneic cell- and tissue donors.
  • Speaks and reads Danish or English

You may not qualify if:

  • Active tobacco use, or use of other nicotine substitutes
  • Active cancer or still in follow-up (5 years)
  • Rheumatologic disease
  • Avascular disease
  • Severe bone deformity
  • Previous infection of the knee joint
  • Pes anserine bursitis
  • pain attributed to diffuse edema
  • pain attributed to displaced meniscal tear or osteochondritis
  • Neurogenic or vascular claudication
  • Bleeding disorders
  • Chemotherapy
  • Radiation therapy to the leg or adipose harvested site
  • Knee injections within 3 months of treatment
  • Unable to discontinue the following drugs 7 days before injections (prescription pain medication, anticoagulation medicine (including ibuprofen), thrombolytics, antiplatelet medication)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanos Clinic Syddanmark

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Jesper Due Jensen, PhD

CONTACT

+45 51222087jj@stemmedical.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2023

First Posted

March 29, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

DK(1)