WithdrawnPhase 1

Mesenchymal Stem Cells (MSCs) for Steroid Refractory Acute GVHD (SR-aGVHD)

Stopped: OSSM-001 will not be used in this program moving forward.

0Started 2023-06-05

Plain-language summary

The objective of this clinical study is to demonstrate safety and feasibility of single-dose infusion of Ossium MSCs product (OSSM-001) to treat steroid refractory acute GVHD (SR-aGVHD).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Minimum 18 years of age who have undergone hematopoietic cell transplantation (HCT), from any donor source donor (including HLA-matched related and unrelated, haploidentical and umbilical cord donors) with any conditioning regimen
✓. Clinically diagnosed Grades II to IV acute GVHD as per standard criteria occurring within 100 days of HCT
✓. Confirmed diagnosis of steroid refractory aGVHD defined as patients administered high-dose systemic corticosteroids (methylprednisolone 2 mg/kg/day \[or equivalent prednisone dose 2.5 mg/kg/day\]), given alone or combined with calcineurin inhibitors (CNI) and either:
✓. Progressing based on organ assessment after at least 3 days at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGVHD, OR
✓. Failure to achieve at a minimum partial response based on organ assessment after 7 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGVHD, OR
✓. Patients who fail corticosteroid taper defined as fulfilling either one of the following criteria:
✓. Minimum Karnofsky Performance Level of at least 30 or higher at the time of study entry.

Exclusion criteria

✕. Has received more than one systemic treatment for steroid refractory aGVHD in addition to steroids.
✕. Received stem cell therapy in the past
✕. Presence of an active uncontrolled infection including significant bacterial, fungal, viral, or parasitic infection requiring treatment
✕. Presence of relapsed primary malignancy, or who have been treated for relapse after the HCT was performed, or who may require rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse.
✕. Evidence of pulmonary infiltrate or hemorrhage based on imaging or requiring high flow oxygen via face mask
✕. Patients who have had treatment with any other investigational agent, device, or procedure within 30days (or 5 half-lives, whichever is greater) prior to enrollment.
✕. Patients who have received more than one HCT
✕. Any medical or psychological condition or situation deemed by the Investigators to put the patient at increased risk of complications or non-compliance.

What they're measuring

Safety events

Timeframe: 112 days (16 weeks)

Trial details

NCT IDNCT05443464

SponsorOssium Health, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-10

View on ClinicalTrials.gov More GVHD,Acute trials