AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery (CRATUS)

Longeveron

Status and phase: Completed; Phase 2; Phase 1

Conditions: Frailty

Treatments: Biological: Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs); Biological: Placebo; Biological: Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02065245

20130646

Details and patient eligibility

About

The purpose of this study is to look at the safety of treatment with stem cells in patients with Frailty.

Enrollment: 65 patients

Sex: All

Ages: 60 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provide written informed consent.
• Subjects age greater than or equal to 60 and less than or equal to 95 years at the time of signing the Informed Consent Form.
• Show signs of frailty apart from a concomitant condition as assessed by the Investigator with a frailty score of 4 to 7 using the Clinical Frailty Scale
• Female subjects with an Follicle-stimulating hormone (FSH) equal to or > 25.8 milli-international units (mIU) /mL (milliliter), if not currently on hormone replacement therapy.

Exclusion criteria

• Score of less than or equal to 24 on the Mini Mental State Examination (MMSE)
• Inability to perform any of the assessments required for endpoint analysis (report safety or tolerability concerns, perform pulmonary function tests, undergo blood draws, read and respond to questionnaires.
• Active listing (or expected future listing) for transplant of any organ.
• Clinically important abnormal screening laboratory values, including but not limited to: hemoglobin <8 g/dl, white blood cell count <3000/mm3, platelets<80,000/mm3, international normalized ratio (INR) > 1.5 not due to a reversible cause (i.e. Coumadin), aspartate transaminase, alanine transaminase, or alkaline phosphatase > 3 times upper limit of normal, total bilirubin > 1.5 mg/dl.
• Serious comorbid illness that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study. Including, but not limited to: HIV, advanced liver or renal failure, class III/IV congestive heart failure, myocardial infarction, unstable angina, or cardiac revascularization within the last six months, or severe obstructive ventilatory defect.
• Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
• Be an organ transplant recipient.
• Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma if recurrence occurs.
• Have a non-pulmonary condition that limits lifespan to < 1 year.
• Have a history of drug or alcohol abuse within the past 24 months.
• Be serum positive for HIV, hepatitis B Surface Antigen (BsAg) or Viremic hepatitis C.
• Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
• Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female patients must undergo a blood or urine pregnancy test at screening and within 36 hours prior to infusion.
• Have hypersensitivity to dimethyl sulfoxide (DMSO)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 7 patient groups

Pilot phase - Group 1

Experimental group

Description:

Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.

Treatment:

Biological: Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)

Pilot Phase - Group 2

Experimental group

Description:

Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.

Treatment:

Biological: Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)

Pilot Phase - Group 3

Experimental group

Description:

Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.

Treatment:

Biological: Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)

Randomized Phase - Group A

Experimental group

Description:

Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion.

Treatment:

Biological: Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)

Randomized phase - Group B

Experimental group

Description:

Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion.

Treatment:

Biological: Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)

Randomized Phase - Group C

Experimental group

Description:

Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval.

Treatment:

Biological: Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)

Biological: Placebo

Addendum B - Antibiotic free cell Group

Experimental group

Description:

Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval.

Treatment:

Biological: Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)

Biological: Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)