Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPD

Purpose

The purpose of this study is to select the safest and most effective number of repeat doses of allogeneic bone marrow-derived mesenchymal stem cell (MSC) infusions to slow the progression of Parkinson's disease (PD).

Condition

  • Parkinson's Disease

Eligibility

Eligible Ages
Between 50 Years and 79 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of Parkinson's disease by the UK brain bank criteria including the presence of 2 cardinal signs of PD plus bradykinesia. - Mild microsomia to anosmia. - A modified Hoehn and Yahr stage of 3 or less. - Date of diagnosis of PD between 3 to 10 years - Robust response to dopaminergic therapy.

Exclusion Criteria

  • Atypical, vascular, or drug-induced Parkinsonism. - An atypical DAT scan or MRI supporting an alternative explanation for PD symptoms. - Patient not on levodopa containing medications. - Clinical features of psychosis or refractory hallucinations. - A Montreal Cognitive Assessment (MoCA) score of less than 25. - Uncontrolled seizure disorder. - Abnormal Kidney and liver function. - Presence of clinically refractory orthostatic hypotension at the screening or baseline visit. - Body mass index of greater than or equal to 35. - Cardiac disease: History of congestive heart failure, clinically significant bradycardia, presence of 2nd, or 3rd-degree atrioventricular block. - Pulmonary disease: COPD with oxygen-requirement at rest or with ambulation; or moderate to severe asthma. - Active malignancy or diagnosis of malignancy within 5 years prior to the start of screening - Any current suicidal ideation or behaviors. - Any diagnosis of autoimmune disease or immunocompromised state - History of medium or large size vessel cerebrovascular accidents. - History of traumatic brain injury with loss of consciousness and residual neurologic symptoms. - Major surgery within the previous 3 months or planned in the ensuing 6 months. - History of use of an investigational drug within 90 days prior to the screening visit. - History of brain surgery for PD. - Substance abuse disorder. - Active anticoagulation treatment and/or abnormal INR.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MSC+placebo 		2 treatment doses + 1 placebo 3 months apart
  • Drug: MSC+placebo
    2 infusions of 10 X 10^6 MSC/kg and 1 placebo every 3 months.
    Other names:
    • allogeneic mesenchymal stem cell or similar placebo
Experimental
MSC 		3 treatment doses 3 months apart
  • Drug: MSC+placebo
    2 infusions of 10 X 10^6 MSC/kg and 1 placebo every 3 months.
    Other names:
    • allogeneic mesenchymal stem cell or similar placebo
  • Drug: MSC
    3 infusions of 10 X 10^6 MSC/kg every 3 months.
    Other names:
    • allogeneic mesenchymal stem cell
Placebo Comparator
Placebo 		3 placebo doses 3 months apart
  • Drug: Placebo
    3 infusions of placebo every 3 months. Placebo will be identical to the investigational product but will not contain MSCs.
    Other names:
    • Similar placebo

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Detailed Description

Single site phase IIa study of allogeneic MSC in a double blind randomized control trial as disease modifying therapy for PD. The design includes three treatment arms with 45 patients.