Clinical trial

A Clinical and Histological Analysis of Mesenchymal Stem Cells in Amputation

Name

1505714405

Description

Patients undergoing semi-elective lower extremity major amputation from complications associated with atherosclerotic limb ischemia will received intra-muscular injections of allogeneic Mesenchymal Stromal Cells in the leg above and below the point of amputation to prevent ischemic wound complications after surgery and decrease the incidence of revision and further amputation. Cohort Groups 1-4 will serve as controls.

Trial arms

Trial start

2017-01-23

Estimated PCD

2023-10-03

Trial end

2024-10-03

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Allogeneic bone marrow derived mesenchymal stem cells

Injection of HLA-A2+ and/or gender mismatched allogeneic MSCs above the site of amputation and into the anterior tibialis muscle (ATM) of patients scheduled for semi-elective lower extremity major amputation at 7 days before amputation.

Arms:

Active/Treatment Group

Other names:

cBMA, MSCs

Size

Primary endpoint

Number of participants with treatment-related adverse events occurring during the enrollment period as assessed by the Investigator using the MeDRA scale.

Primary follow up in a 6 month period

Eligibility criteria

Inclusion Criteria: 1. Be ≥ 40 and ≤90 years of age. 2. Patients requiring lower extremity major amputation, as determined by an independent vascular specialist. 3. If ulceration or gangrene present, it is distal to malleoli (to allow adequate length of ATM area of approximately 3cm x 10cm x 3 cm) 4. Amputation can safely be performed up to 30 days after screening, as determined by an independent vascular or orthopedic surgeon. 5. Females of childbearing potential must be willing to use one form of birth control for the duration of the study. Female participants must undergo a blood or urine pregnancy test at screening. Exclusion Criteria: 1. Patients who are pregnant, planning to become pregnant in the next 12 months, or lactating. 2. CHF hospitalization within the last 1 month prior to enrollment.\* 3. Acute coronary syndrome in the last 1 month prior to enrollment.\* 4. HIV positive, or active, untreated HCV as determined by review of medical records. 5. History of cancer within the last 5 years, except basal cell skin carcinoma 6. Inability to provide written informed consent due to cognitive or language barriers (interpreter permitted). 7. Concurrent enrollment in another clinical investigative trial that may alter the outcomes of enrollment in this trial. 8. Any condition requiring immunosuppressant medications (e.g., for treatment of organ transplants, psoriasis, Crohn's disease, alopecia areata). 9. Presence of any clinical condition that in the opinion of the PI or the sponsor makes the patient not suitable to participate in the trial. * As defined by the standard definitions of CHF and ACS by the American Heart Association.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 81, 'type': 'ACTUAL'}}

Updated at

2024-04-09

1 organization

1 product

9 indications

Organization

Indiana University

Product

Allogeneic bone marrow derived mesenchymal stem cells

Indication

Ischemia

Indication