NCT07542808

Brief Summary

StromaForte injection for knee OA

Trial Health

77
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
17mo left

Started Apr 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress2%
Apr 2026Sep 2027

First Submitted

Initial submission to the registry

April 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

April 27, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

April 15, 2026

Last Update Submit

April 15, 2026

Conditions

Knee Arthritis Osteoarthritis

Keywords

CellcolabsKnee OAMesenchymal stem cellsCell therapy

Outcome Measures

Primary Outcomes (1)

  • To show that StromaForte single dose treatment provides superior pain reduction from baseline to 6 months post-injection compared to hyaluronic acid single dose treatment.

    Change from baseline in subjective pain during activity assessment according to the Visual Analogue Scale (VAS) questionnaire at 6 months ±30 days post-injection.

    "From enrollment to the end of follow-up at 1 year

Secondary Outcomes (2)

  • To evaluate the effect of StromaForte single dose treatment on pain reduction from baseline to 3 months and 12 months post-injection, compared to hyaluronic acid single dose treatment.

    From enrollment to the end of follow-up at 1 year

  • To evaluate the effect of StromaForte single dose treatment on improvement of the patient's functional ability at 3 months, 6 months and 12months post-injection, compared to hyaluronic acid single dose treatment.

    From enrollment to the end of follow-up at 1 year

Study Arms (2)

StromaForte- Mesenchymal Stem cells

EXPERIMENTAL

Human Allogenic Bone marrow derived Mesenchymal Stem cells

Other: Mesenchymal Stem Cells (MSC)

Hyaluronic Acid

ACTIVE COMPARATOR

Hyaluronic Acid

Other: Hyaluronic Acid (HA)

Interventions

Mesenchymal Stem Cells (MSC)OTHER

StromaForte

StromaForte- Mesenchymal Stem cells
Hyaluronic Acid (HA)OTHER

Hyaluronic Acid

Hyaluronic Acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to provide written informed consent and comply with all procedures required by the protocol.
  • Aged ≥ 18 years at the time of signing the informed consent form.
  • Diagnosed with knee osteoarthritis (OA) based on the criteria established by the American College of Rheumatology, confirmed through radiological images no older than three months.
  • Grade I to IV osteoarthritis on the Kellgren-Lawrence radiological classification scale.
  • Joint pain during activity as assessed by the Visual Analogue Scale (VAS) of ≥ 40 at the time of screening
  • Body Mass Index (BMI) between ≥ 18.5 to ≤ 35.0 kg/m2

You may not qualify if:

  • Unwilling or unable to perform any of the assessments required by the protocol.
  • Mechanically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear.
  • Varus or valgus malalignment \>5 degrees as measured by 4-foot standing antero-posterior radiographs.
  • History of subtotal medial or lateral meniscectomy performed less than 9 months ago.
  • History of septic arthritis in the targeted knee.
  • History of infectious or inflammatory joint disorders or suspected infective or inflammatory joint disease.
  • Systemic or intra-articular injection of corticosteroids in any joint within 3 months before screening.
  • Immunosuppression due to illness or medication including but not limited to high dose corticosteroids, calcineurin inhibitors, anti-TNF, anti-IL-6, anti-p40, biologics and prednisone and/or equivalent over 5 mg/day.
  • Planned orthopaedic surgery on lower limbs within the next 12 months
  • Active or suspected infection.
  • History of malignancy in the past 2.5 years, except in-situ cancers treated by local excision with curative intent.
  • Severe bleeding diathesis.
  • Pregnancy or breastfeeding.
  • Unwilling or for medical reason not recommended to pause anticoagulant medications prior to procedure, as judged by prescribing doctor.
  • Known diagnosis of HIV-1, HIV-2, Hepatitis A, Hepatitis B, Hepatitis C, HTLV-I/II, or Syphilis, or other acute or chronic infectious disease.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burjeel Medical City

Abu Dhabi, United Arab Emirates

RECRUITING

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Ola Jeppsson

    Cellcolabs Clinical SPV Limited

    STUDY DIRECTOR

Central Study Contacts

Bahar Kasaei

CONTACT

+971506845410hello@cellcolabs.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 21, 2026

Study Start

April 27, 2026

Primary Completion (Estimated)

September 27, 2027

Study Completion (Estimated)

September 27, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

AE(1)