search
Back to results

An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Not yet recruiting
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
STEM-OA
Sponsored by
StemMedical A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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) Use of oral glucocorticoids. Female who is pregnant, breast-feeding or intends to become pregnant within 1-year after the treatment, or is of child-bearing potential and not using highly effective contraceptive method. Known chronic disease associated with metabolism malfunction or poor healing. Allergy towards necessary anaesthesia Varus/valgus malalignment >5° Isolated patellofemoral arthrosis

Sites / Locations

  • Sanos Clinic Syddanmark

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

autoSTEM-OA 400

alloSTEM-OA 400

autoSTEM-OA 800

alloSTEM-OA 800

autoSTEM-OA 1600

alloSTEM-OA 1600

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

STEM-OA safety
Number of treatment emergent adverse events (TEAEs)

Secondary Outcome Measures

Knee pain
Change in KOOS 'pain' score
Number of treatment responders
Number of treatment responders according to the OMERACT-OARSI criteria

Full Information

First Posted
March 16, 2023
Last Updated
March 16, 2023
Sponsor
StemMedical A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT05789719
Brief Title
An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis
Official Title
An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
StemMedical A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
autoSTEM-OA 400
Arm Type
Experimental
Arm Description
400x10^6 autologous MSC(AT)s in autologous fat
Arm Title
alloSTEM-OA 400
Arm Type
Experimental
Arm Description
400x10^6 allogeneic MSC(AT)s in autologous fat
Arm Title
autoSTEM-OA 800
Arm Type
Experimental
Arm Description
800x10^6 autologous MSC(AT)s in autologous fat
Arm Title
alloSTEM-OA 800
Arm Type
Experimental
Arm Description
800x10^6 allogeneic MSC(AT)s in autologous fat
Arm Title
autoSTEM-OA 1600
Arm Type
Experimental
Arm Description
1600x10^6 autologous MSC(AT)s in autologous fat
Arm Title
alloSTEM-OA 1600
Arm Type
Experimental
Arm Description
1600x10^6 allogeneic MSC(AT)s in autologous fat
Intervention Type
Biological
Intervention Name(s)
STEM-OA
Intervention Description
Combination of autologous or allogeneic MSC(AT)s and fat
Primary Outcome Measure Information:
Title
STEM-OA safety
Description
Number of treatment emergent adverse events (TEAEs)
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Knee pain
Description
Change in KOOS 'pain' score
Time Frame
13 weks
Title
Number of treatment responders
Description
Number of treatment responders according to the OMERACT-OARSI criteria
Time Frame
13 weks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) Use of oral glucocorticoids. Female who is pregnant, breast-feeding or intends to become pregnant within 1-year after the treatment, or is of child-bearing potential and not using highly effective contraceptive method. Known chronic disease associated with metabolism malfunction or poor healing. Allergy towards necessary anaesthesia Varus/valgus malalignment >5° Isolated patellofemoral arthrosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesper Due Jensen, PhD
Phone
+45 51222087
Email
jj@stemmedical.com
Facility Information:
Facility Name
Sanos Clinic Syddanmark
City
Vejle
ZIP/Postal Code
7100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis

We'll reach out to this number within 24 hrs