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Wharton´s Jelly Derived Mesenchymal Stromal Cell Repeated Treatment of Adult Patients Diagnosed With Type I Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03973827
Recruitment Status : Active, not recruiting
First Posted : June 4, 2019
Last Update Posted : April 3, 2023
Sponsor:
Information provided by (Responsible Party):
NextCell Pharma Ab

Study Description
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Brief Summary:
An open label, parallel single centre trial of Wharton's Jelly derived allogenic mesenchymal stromal cells repeated treatment to preserve endogenous insulin production in adult patients diagnosed with type 1 diabetes

Condition or disease Intervention/treatment Phase
Type1diabetes Drug: ProTrans Drug: Placebo Phase 1 Phase 2

Detailed Description:
This is a phase (I)/II study, and the purpose of this study is to determine whether, in adult patients diagnosed for type 1 diabetes, a repeated allogeneic infusion of WJMSCs is safe and to study changes in beta-cell function, metabolic control and Diabetes Treatment Satisfaction. The study population will consist of 18 adult male patients, 18-41 years of age (inclusive at both ends) diagnosed (<3,5 years) with type 1 diabetes mellitus.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Parallel Single Center Trial of Wharton's Jelly Derived Allogeneic Mesenchymal Stromal Cells Repeatedly Treated to Preserve Endogenous Insulin Production in Adult Patients Diagnosed With Type 1 Diabetes
Actual Study Start Date : May 17, 2019
Actual Primary Completion Date : December 10, 2020
Estimated Study Completion Date : October 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Low dose
3 patients receiving low dose
 Drug: ProTrans
Single infusion of 25, 100 or 200 million cells per patient.
Other Name: Allogeneic transplantation with WJMSCs
Experimental: Medium dose
3 patients receiving medium dose
 Drug: ProTrans
Single infusion of 25, 100 or 200 million cells per patient.
Other Name: Allogeneic transplantation with WJMSCs
Experimental: High dose
3 patients receiving high dose
 Drug: ProTrans
Single infusion of 25, 100 or 200 million cells per patient.
Other Name: Allogeneic transplantation with WJMSCs
Sham Comparator: Control
6 patients
 Drug: Placebo
Placebo Comparator: Sham transplantation (placebo) Single infusion with albumin and dmso in sodium chloride (identical concentrations as active treatment)
Other Name: Placebo treatment


Outcome Measures
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Primary Outcome Measures :
  1. The primary safety endpoint in this study is; safety parameters include adverse events, hypoglycemia and allergic reactions [ Time Frame: 372 days ]
    To investigate the safety and tolerance after a repeated allogeneic infusion of Whartons Jelly Mesenchymal Stromal Cells (WJMSCs) intravenously in adult patients diagnosed with type 1 diabetes after one year following the repeated treatment.

  2. Delta-change of C-peptide AreaUnder the Curve (AUC) (0-120 min) for Mixed Meal Tolerance Test (MMTT) at day 372 following WJMSC infusion when compared to test performed before start of treatment. [ Time Frame: 372 days ]
    To study changes in insulin requirements during one year following treatment .


Secondary Outcome Measures :
  1. Number of patients insulin independent (ADA criteria) at day 372. [ Time Frame: 372 days ]
    To study changes in insulin requirements during one year following treatment .

  2. Number of patients with daily insulin needs <0.25U/kg at day 372. [ Time Frame: 372 days ]
    To study changes in insulin requirements during one year following treatment .

  3. HbA1c at day 372 [ Time Frame: 372 days ]
    To study changes in HbA1c during one year following treatment.

  4. Glucose variability (mean amplitude of glycaemic excursions and glycaemic lability index) duration derived from the continuous glucose monitoring system® at day 372 [ Time Frame: 372 days ]
    To study changes in glucose levels during one year following treatment.

  5. Delta change of levels of fasting C-peptide at day 372 when compared to test before start of treatment [ Time Frame: 372 days ]
    To study changes in fasting C-peptide levels during one year following treatment.

  6. Numbers of patients with peak C-peptide >0.20 nmol/l, in response to the MMTT, at day 372. [ Time Frame: 372 days ]
    To study changes in C-peptide levels during one year following treatment.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A new written informed consent for participation of the study is required to be given before undergoing any study-specific procedures.
  2. Only patients that have previously been dosed by the IMP according to protocol Protrans-1 are eligible for a second dose of Protrans.
  3. No identified IMP related on-going adverse event, neither history of any adverse event that is evaluated potentially to be related to the previous IMP dosing in Protrans I.
  4. Clinical history compatible with type 1 diabetes diagnosed less than 3 years before enrolment. This also includes control patients not receiving IMP.
  5. Only male patients between 18-41 years of age will be included.
  6. Mentally stable and, in the opinion of the investigator, able to comply with the procedures of the study protocol.

Exclusion Criteria:

  1. Inability to provide informed consent
  2. Patients with body mass index (BMI) > 30, or weight >100 kg
  3. Patients with weight <50 kg
  4. Patients with unstable cardiovascular status incl. NYHA class III/IV or symptoms of angina pectoris.
  5. Patients with uncontrolled hypertension (≥160/105 mmHg).
  6. Patients with active on-going infections.
  7. Patients with latent or previous as well as on-going therapy against tuberculosis, or exposed to tuberculosis or has travelled in areas with high risk of tuberculosis or mycosis within the last 3 months.
  8. Patients with serological evidence of infection with HIV, Treponema pallidum, hepatitis B antigen (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.
  9. Patients with any immune suppressive treatment
  10. Patients with known demyelinating disease or with symptoms or physical examination findings consistent with possible demyelinating disease.
  11. Patients with known, or previous, malignancy.
  12. Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin
  13. Patients with GFR <80 ml/min/1.73 m2 body surface
  14. Patients with proliferative retinopathy
  15. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with MSC.
  16. Known hypersensitivity against any excipients, i.e. dimethyl sulfoxide (DMSO).- This criterion is only applicable to patients which receive study drug.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973827


Locations
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Sweden
Karolinska Trial Alliance, Fas 1 enheten, Karolinska Universitetssjukhuset Huddinge
Huddinge, Sweden
Sponsors and Collaborators
NextCell Pharma Ab
Investigators
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Principal Investigator: Per-Ola Carlsson, PhD Uppsala University
More Information
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Responsible Party: NextCell Pharma Ab
ClinicalTrials.gov Identifier: NCT03973827    
Other Study ID Numbers: ProTrans-Repeat
2018-004158-11 ( EudraCT Number )
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: April 3, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NextCell Pharma Ab:
type 1 diabetes
diabetes
MSC's
Mesenchymal
 Stem Cells
Stromal
Wharton´s Jelly
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases